Medical Device Incident Report Checklist
Comprehensive medical device incident documentation for FDA MedWatch reporting including device identification, event details, and patient outcome.
- Industry: Healthcare
- Frequency: Per incident
- Estimated Time: 30-45 minutes
- Role: Risk Management/Clinical Staff
- Total Items: 32
- Compliance: FDA MDR 21 CFR 803, Safe Medical Devices Act, Joint Commission
Device Identification
Identify the device
- Device name/type documented?
- Manufacturer documented?
- Model number documented?
- Serial number documented?
- Lot number documented (if applicable)?
Event Description
What happened
- Event fully described?
- Device malfunction documented?
- Potential usage error assessed?
- Witnesses documented?
Patient Outcome
Patient impact
- Patient injury documented?
- Treatment required documented?
- Patient outcome documented?
Device Preservation
Evidence preservation
- Device preserved and quarantined?
- Packaging preserved (if applicable)?
- Chain of custody maintained?
Reporting Requirements
Regulatory reporting
- FDA MedWatch report required?
- Manufacturer notified?
- Risk management notified?
Pre-Assessment Information
Initial assessment documentation and patient/facility identification
- Assessor Name / Credentials
- Assessment Date
- Department / Unit
- Assessment Type (Routine/Annual/Complaint)
- Previous assessment findings reviewed?
Infection Prevention & Control
Verify infection control practices per CDC and Joint Commission standards
- Hand hygiene compliance observed?
- Appropriate PPE available and properly used?
- Isolation precautions properly implemented?
- Sharps containers available and not overfilled?
- High-touch surfaces properly disinfected?
Patient Safety & Identification
Verify patient safety protocols and identification procedures
- Two patient identifiers used before procedures?
- Fall risk assessment completed?
- Call light within patient reach?
- Bed in lowest position with brakes locked?
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Why Use This Medical Device Incident Report Checklist?
This medical device incident report checklist helps healthcare teams maintain compliance and operational excellence. Designed for risk management/clinical staff professionals, this checklist covers 32 critical inspection points across 8 sections. Recommended frequency: per incident.
Ensures compliance with FDA MDR 21 CFR 803, Safe Medical Devices Act, Joint Commission. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Medical Device Incident Report Checklist cover?
This checklist covers 32 inspection items across 8 sections: Device Identification, Event Description, Patient Outcome, Device Preservation, Reporting Requirements, Pre-Assessment Information, Infection Prevention & Control, Patient Safety & Identification. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed per incident. Each completion takes approximately 30-45 minutes.
Who should use this Medical Device Incident Report Checklist?
This checklist is designed for Risk Management/Clinical Staff professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.