Provide precise equipment identification to enable rapid asset tracking and maintenance history retrieval. All starred fields are mandatory for immediate processing.
Equipment Asset ID Number
Equipment Official Name
Manufacturer
Model Number
Serial Number
Equipment Category
Patient Monitoring
Life Support
Imaging & Diagnostics
Surgical & Interventional
Laboratory & Analytical
Therapeutic & Infusion
IT & Data Management
Infrastructure & Utility
Other
Primary Department/Unit Location
Specific Room/Area
Building and Floor
Date of Last Preventive Maintenance
Date of Last Calibration
Is the equipment currently under warranty or service contract?
Provide warranty or contract details
Explain warranty expiration or coverage gap
Equipment Age in Years
Responsible Supervising Department
Detail the exact circumstances of the malfunction to facilitate accurate technical diagnosis and contextual risk evaluation. Include temporal sequence and environmental conditions.
Exact Date and Time of Failure
Was the equipment actively in use for direct patient care when the malfunction occurred?
Specify the patient care activity or procedure in progress
Describe the operational status and intended next use
Which primary function or subsystem failed?
Power/Electrical
Display/Visual Output
Alarm/Alert System
Sensor/Probe Input
Mechanical Component
Software/Firmware
Network/Connectivity
Cooling/Environmental Control
User Interface/Controls
Data Storage/Transmission
Multiple Functions
Unknown
Detailed Description of Malfunction and Observed Symptoms
Error Messages or Fault Codes Displayed
Was a backup or redundant device immediately available and functional?
Was the backup device successfully deployed and used?
Specify backup device asset ID used
Explain why backup was not utilized
Describe the contingency plan implemented
Select all environmental or operational conditions present at time of failure
Normal power supply
Unstable/fluctuating power
Recent power outage
High ambient temperature
High humidity
Recent physical impact/movement
Recent cleaning or disinfection
Network congestion
Concurrent equipment use nearby
Staff training session in progress
None of the above
Has this equipment undergone any repairs, modifications, or software updates in the past 7 days?
Describe the recent work performed and date
Primary operator's training level on this equipment
Certified super-user
Routine trained staff
Newly trained (<30 days)
Emergency cross-coverage
Student/trainee
Not applicable (device not in active use)
Any unusual observations, warnings, or performance degradation noted in the 48 hours preceding this failure?
Evaluate and document any direct or potential consequences for patient safety, clinical outcomes, and care continuity. This section is critical for immediate risk mitigation and patient safety monitoring.
Did the malfunction involve or affect a patient directly?
How many patients were directly affected or exposed?
What was the proximity to patient care areas?
Patient Safety Impact Severity Rating
No impact (purely technical)
Minor impact (no harm, no care delay)
Moderate impact (care delay <30 min, no clinical harm)
Major impact (care delay >30 min or temporary clinical deterioration)
Severe impact (permanent harm or death)
Describe the clinical deterioration and immediate interventions required
Provide detailed account of the adverse outcome and immediate response
Was there any interruption, delay, or cancellation of scheduled patient care procedures?
Specify which procedures were affected and the duration of delay
Were alternative clinical arrangements successfully implemented without compromising patient safety?
Explain the gap in care and any compensatory measures taken
Has a formal adverse event or incident report been filed in the patient safety system?
Provide the incident report reference number
Justify why no adverse event report was warranted
Name and role of staff member operating the equipment at time of failure
Were there any witnesses to the malfunction event?
List names and roles of witnesses
Immediate actions taken by staff to ensure patient and staff safety
Did the malfunction result in any physical injury to patients or staff?
Describe the injury, affected individual(s), and medical treatment provided
Document all actions taken to isolate the faulty equipment and engage technical support. Proper quarantine prevents inadvertent reuse and ensures timely repair workflow.
Has the equipment been physically quarantined and removed from service immediately?
Name of person who authorized quarantine
Explain why equipment could not be quarantined and what interim safety measures are in place
Date and Time of Quarantine
Has the Biomedical Engineering or Clinical Engineering department been formally notified of this failure?
Biomedical Engineering case or ticket number
Provide justification for not notifying biomedical engineering and alternative plan
Date and Time of Biomedical Notification
Has a physical 'Out of Service' tag or lockout been applied to the equipment?
Explain the barrier to tagging and how staff will be informed
Have photographs or video documentation of the equipment, error displays, and physical condition been captured?
Upload captured media files here
Explain why visual documentation was not obtained
Repair Priority Assessment
Emergency (immediate patient safety risk)
Urgent (affects critical care within 24h)
High (affects scheduled procedures)
Medium (affects routine operations)
Low (non-critical, backup available)
Estimated Downtime or Repair Duration
Has a loaner or replacement equipment been requested?
Loaner request reference number
Has physical access to the equipment been restricted to authorized personnel only?
Describe access control limitations
Complete risk assessment and obtain necessary oversight approvals. This section ensures organizational learning, trend analysis, and accountability for patient safety interventions.
Has a preliminary risk assessment been completed for this equipment failure event?
Explain the reason risk assessment was not performed
Overall Risk Level Classification
Low (minimal impact, contained)
Medium (moderate impact, manageable)
High (significant impact, requires intervention)
Critical (severe impact, immediate action required)
Have there been any similar equipment failures or malfunctions involving this same device or model in the past 30 days?
How many similar incidents in the past 30 days?
Confirm that you have checked the incident reporting system
Does this event suggest a potential trend or systemic issue requiring deeper investigation?
Describe the trend concerns and recommended investigation scope
Has the Patient Safety Officer or Risk Management Lead been formally notified of this event?
Date and Time of notification
Justify why Patient Safety Lead was not notified
Select all follow-up actions that are required based on this event
Equipment manufacturer notification
Regulatory authority reporting
Root cause analysis (RCA)
Failure Mode Effects Analysis (FMEA)
Staff retraining
Policy/procedure revision
Equipment replacement evaluation
Preventive maintenance schedule review
No further action required
Planned corrective actions to address immediate causes
Planned preventive actions to avoid recurrence
Target Date for Completion of Follow-up Actions
Patient Safety or Risk Management Lead Approval Signature
Additional Comments or Recommendations
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