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Welcome to ECRI Institute's Medical Device Safety Reports (MDSR) database. MDSR is a
repository of medical device incident and hazard information independently investigated by ECRI Institute, a nonprofit health research agency. MDSR is not an alerting service, but a periodically updated review of the types of problems that have occurred with medical devices and lessons learned over the past three decades. It focuses on the steps that medical device users can take to prevent or reduce medical device risks to patient care and healthcare worker safety. You can search through MDSR by using either the criteria provided in the picklists or by using the free text search box below. For current alerts and a historical database see our Health Devices Alerts database.
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Cause of Device-Related Incident
Clinical Specialty or Hospital Dept:
Device Factors:
(Any of the following)
*Not stated
Device factors
External factors
Support system failures
Tampering and/or sabotage
User errors
(Any of the following)
*Not stated
Anesthesia
Cardiology/Cardiac Catheterization
Cardiopulmonary Perfusion
Cardiothoracic Surgery
CCU/ICU/NICU
Clinical Laboratory
Clinical/Biomedical Engineering
Continuing Care
CSR/Materials Management
Dermatology
Dialysis
Emergency Medicine
Facilities Engineering
Gift Shop
Home Healthcare
Infection Control
Medical Records
Neonatology
Nephrology
Neurological Surgery
Neurology
Nursery
Nursing
Obstetrics and Gynecology
Oncology
Ophthalmology
OR/Surgery
Orthopedics
Otolaryngology
Pathology
Pediatrics
Pharmacy/IV therapy
Physical Medicine/Rehabilitation
Proctology
Psychiatry
Pulmonary/Respiratory Therapy
Radiology/Ultrasound/Nuclear Med.
Surgical Pathology
Urology
(Any of the following)
*Not stated
Design/labeling error
Device failure
Device interaction
Failure of accessory
Improper maintenance, testing, repair, or lack or failure of incoming inspection
Improper modification
Invalid device foundation
Manufacturing error
Packaging error
Random component failure
Document Type:
External Factors:
Mechanism of Injury or Death:
(Any of the following)
Checklists/Emergency Procedures
Frequently Asked Questions (FAQ)
Guidance Articles
Hazard Reports
Posters
User Experience Network (UEN) reports
(Any of the following)
*Not stated
Electromagnetic or radio-frequency interference (EMI and RFI)
Environmental (temperature, humidity, light)
Medical gas and vacuum supplies
Power supply (including piped medical gases)
Water supply
(Any of the following)
*Not stated
Anaphylaxis
Barotrauma
Blindness
Burn (electrical, thermal, chemical)
Coagulopathy
Electrical shock/electrocution
Embolism (gaseous or particulate)
Exposure to airborne infectious agents
Exposure to biohazards
Exposure to bloodborne pathogens
Exposure to hazardous gas
Exsanguination
Extravasation
Failure to deliver therapy
Fire
Hemolysis
Hemorrhage
Hyperthermia
Infection
Infiltration
Interruption of therapy
Ischemia
Mechanical (puncture, perforate, lacerate, break, cut, tear, nick, crush)
Misdiagnosis
Monitoring failure
Overdose
Particulates
Skin Injury
Suffocation
Underdose
Various
Wrong drug
Support System Failures:
Tampering and/or Sabotage:
User Errors:
(Any of the following)
*Not stated
Error in hospital policy
Failure to train and/or credential
Improper storage
Lack of competent accident investigation
Lack or failure of incoming and pre-use inspections
Poor prepurchase evaluation
Use of inappropriate devices
(Any of the following)
*Not stated
Tampering
(Any of the following)
*Not stated
Abuse of device
Accidental misconnections
Accidental spill
Device misassembly
Failure to perform pre-use inspection
Failure to read label
Improper connection
Inappropriate reliance on an automated feature
Incorrect clinical use
Incorrect control settings
