Comprehensive Investigation Report for Proprietary Medical Hardware Field Failures

1. Section 1: Device Model, Serial Number & Healthcare Facility Metadata

This section captures essential identification and traceability information for the affected device and reporting healthcare institution. Complete all fields with exact values from device labeling and facility records.

Device Model Number

Device Serial Number

Device Firmware Version

Hardware Revision Level

Device Manufacturing Date

Date of Device Installation/Commissioning at Facility

Date of Last Preventive Maintenance

Healthcare Facility Legal Entity Name

Facility Department/Unit Where Device is Used

Facility Contact Person Full Name

Contact Person Professional Title/Credentials

Contact Person Direct Phone Number

Contact Person Official Email Address

Facility Accrediting Body Identifier

Is the device part of a networked system or standalone?

Yes

No

Describe network topology and connected systems:

Continue with standalone device assessment.

Associated Accessories or Consumables Used During Incident

	Accessory/Consumable Name	Part Number	Lot/Batch Number	Expiration Date	Suspected Role in Malfunction?
	A	B	C	D	E
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2. Section 2: Malfunction Description & Patient Outcome Summary

Provide a comprehensive narrative of the device malfunction and any resulting patient impact. This section is critical for risk assessment and regulatory determination. Be precise and include all observable symptoms and consequences.

Detailed Description of Malfunction or Observed Defect

Exact Date and Time of Malfunction Discovery

Device Operational Mode When Malfunction Occurred

Was the device actively involved in patient treatment when the malfunction occurred?

Yes

No

Describe the specific treatment or procedure being performed:

Did the malfunction result in any direct or indirect patient harm, injury, or adverse outcome?

Yes

No

Patient Harm Severity Assessment

	No Harm	Minor	Moderate	Serious	Critical/Death
Degree of physical injury or physiological impact
Required medical intervention to address harm
Duration of harm or recovery time
Impact on patient quality of life
Potential for long-term sequelae

Potential Severity of Harm (if no actual harm occurred)

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Patient Outcome Narrative (if applicable)

Number of Patients Potentially Exposed to Malfunctioning Device

Was alternative equipment or manual procedure successfully implemented?

Yes

No

Describe alternative method and any resulting clinical impact:

Explain why alternative could not be implemented and resulting clinical impact:

Has this specific malfunction been reported to any regulatory authority?

Yes

No

Provide regulatory reference numbers and submission dates:

Regulatory Reporting Obligation Assessment (per internal policy)

Reportable Serious Incident (Immediate)

Reportable Incident (Timeline)

Non-Reportable (Internal Tracking Only)

Undetermined (Requires Further Review)

Target Regulatory Submission Deadline

Describe information gaps preventing determination:

Upload Device Error Logs or System Dump Files

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Upload Photographs of Device Display, Error Screens, or Physical Damage

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Upload Patient Monitoring Data or Treatment Records (if applicable and legally permissible)

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3. Section 3: Device Return & Containment Quarantine Checklist

This section ensures proper physical control of the suspect device to preserve forensic evidence and prevent further use. Complete all steps before device transport.

Has the device been physically removed from service and tagged as 'Quarantined - Do Not Use'?

Yes

No

Date/Time of Quarantine

Explain why device remains in service and immediate risk mitigation measures:

Is there any suspicion of biological, chemical, or radioactive contamination on the device?

Yes

No

Describe other contamination type:

Has the device been properly decontaminated per facility protocol?

Yes

No

Decontamination Method and Agent Used:

Explain decontamination status and safety precautions for handling:

Are all original accessories, cables, and consumables being returned with the device?

Yes

No

List all components included in return shipment:

Explain missing components and their potential relevance to investigation:

Physical Condition of Device at Time of Quarantine

Has a secure chain of custody been established for device transport?

Yes

No

Document custody transfer details and authorized personnel:

Scheduled Pickup Date for Device Return

Priority Level for Device Return Shipment

Emergency Same-Day Courier

Next Business Day Express

Standard 2-3 Day

Scheduled with Next Field Service Visit

Has a replacement device been provided to the facility?

Yes

No

Replacement Device Serial Number:

Upload Completed Quarantine Tag Photograph

Choose a file or drop it here

Upload Decontamination Certificate or Verification Record

Choose a file or drop it here

4. Section 4: Root Cause Forensic Analysis & CAPA Assessment

This section initiates the systematic investigation process to identify root cause and determine appropriate corrective and preventive actions. Assign responsibilities and timelines for each action item.

Suspected failed component(s) and failure mode:

Suspected software module and error type:

Describe training gap or user interface issue:

Describe maintenance procedure deficiency:

Describe design specification non-conformance:

Describe manufacturing process deviation:

Describe environmental condition exceeded (temperature, humidity, altitude, etc.):

Risk Assessment Matrix: Assign probability and severity scores


Probability of Recurrence (1=Very Unlikely, 5=Certain)
Severity of Potential Harm (1=No Harm, 5=Death)
Detectability Before Harm (1=Always Detected, 5=Never Detected)
Number of Devices in Field with Similar Risk Profile

Calculated Risk Priority Number (RPN = Probability x Severity x Detectability)

Does this issue warrant a field-wide safety notification or recall?

Yes

No

Investigation Team Assignment & Timeline

	Team Member Name	Role/Department	Investigation Task	Assigned Date	Target Completion Date	Priority (1=Low, 5=Critical)
	A	B	C	D	E	F
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Are there any similar complaints or trends in the complaint database?

Yes

No

List related complaint numbers and similarity assessment:

Immediate Interim Containment Actions Taken

Target Date for Final Investigation Report Completion

5. Section 5: Regulatory Affairs Director & Quality Assurance Head Sign-Off

Final governance and accountability section. All assessments must be reviewed and approved by designated authority before case closure. Electronic signatures constitute formal approval.

Has Regulatory Affairs reviewed and confirmed reporting obligations?

Yes

No

Final Regulatory Determination

Reported to Competent Authority (Reference # Obtained)

Reportable - Pending Submission

Not Reportable - Documented Justification

Voluntary Notification Sent

Regulatory Affairs Justification for Reporting Determination

Does this investigation trigger any post-market surveillance reporting (e.g., Periodic Safety Update Report)?

Yes

No

Associated PSUR or PMS Report Reference:

Regulatory Affairs Director Full Name

Regulatory Affairs Director Professional Credentials

Regulatory Affairs Director Electronic Signature

Regulatory Affairs Director Sign-Off Date/Time

Quality Assurance Head Full Name

Quality Assurance Head Professional Credentials

Quality Assurance Head Electronic Signature

Quality Assurance Head Sign-Off Date/Time

Do both directors agree that investigation is complete and all actions are appropriate?

Yes

No

Describe outstanding issues and required additional actions:

Investigation Case Number