When Equipment Fails: Reporting Obligations & Post-Failure Testing
When Patient Care-Related Electrical Equipment (PCREE) fails testing, facilities must immediately remove the device from service, document the event, and follow NFPA 99, FDA, and CMS reporting expectations. Post-failure testing and root cause analysis are critical to ensure safety, avoid repeat issues, and demonstrate compliance to surveyors.
Why Equipment Failure Matters
PCREE failures are not just technical issues — they’re patient safety risks. A failed bed, infusion pump, or ventilator could harm residents and put the facility out of compliance with CMS survey requirements.
Surveyors expect facilities to have clear procedures for what happens when equipment doesn’t pass a PCREE test. Failing to act quickly and document the steps can lead to deficiencies, fines, or worse: resident harm.
Step 1: Remove the Device from Service
The first response is immediate:
Tag the device as failed.
Remove it from the patient area so it cannot be used.
Log the failure in your PCREE testing records.
Surveyors often check whether failed devices are clearly marked and inaccessible.
Step 2: Document the Failure
CMS surveyors and NFPA 99 standards require thorough documentation, including:
Equipment details (model, serial, location).
Date and type of test performed.
Test results (e.g., leakage current exceeded 100 µA).
Technician’s name and signature.
Initial corrective action (removed from service).
Without this paper trail, surveyors will treat the failure as unmanaged risk.
Step 3: Regulatory Reporting Obligations
Some failures go beyond internal logging and require external reporting:
FDA (Medical Device Reporting – MDR): If a device failure could result in serious injury or death, facilities must report it to the FDA under 21 CFR Part 803.
CMS/State Agency: Surveyors may require evidence of how failures were addressed during inspections. Not reporting or hiding device failures is a compliance violation.
Manufacturer Notification: Contact the manufacturer if the failure appears systemic or is under recall.
Step 4: Post-Failure Testing
Before a device can be put back into service, it must pass a post-repair inspection, which usually includes:
Leakage current testing.
Ground resistance testing.
Functional checks.
Verification against NFPA 99 thresholds.
If the device cannot be repaired to standard, it must be decommissioned and replaced.
Step 5: Root Cause Analysis
A single failure can reveal bigger problems. Conduct a root cause analysis to determine:
Was the failure due to aging equipment or poor maintenance?
Did staff skip scheduled tests?
Was the environmental condition (humidity, outlet integrity) a contributing factor?
Are multiple devices of the same model showing similar issues?
Facilities that treat failures as isolated events often repeat mistakes. Those that analyze and adapt demonstrate proactive compliance.
Case Example
The Situation: A facility’s patient lift failed leakage current testing (over 350 µA). The device had been used daily without inspection for nearly two years.
The Response: Staff removed it from service, logged the failure, and contacted the manufacturer. Post-repair testing showed the lift was safe, but the facility also updated its testing schedule to include all lifts every 12 months.
The Result: At their next CMS survey, inspectors reviewed the logs and corrective actions. No deficiency was cited because the facility had documented and resolved the issue.
Best Practices for Handling Failures
Act Fast: Remove and tag failed devices immediately.
Document Everything: Include test results, actions, and technician details.
Know Your Reporting Duties: FDA, CMS, and manufacturers must be informed when appropriate.
Don’t Reuse Until Tested: Post-repair verification is mandatory.
Look for Patterns: Use failures to improve your preventive program.
Key Takeaways
PCREE failures are both safety risks and compliance risks.
CMS surveyors expect documentation of failures and corrective actions.
FDA reporting rules may apply if patient harm is possible.
Root cause analysis turns failures into opportunities for safer, stronger programs.
Resources
NFPA 99 Health Care Facilities Code
CMS State Operations Manual
FDA Medical Device Reporting (MDR)
OSHA Healthcare Electrical Safety
Reviewed by the PCREE Test Compliance Team
Last Updated: September 2025