FDA Adverse Event Malfunction Summary report: N

HERCULES PATIENT REPOSITIONER

MDR report key: 22188312 · Received June 11, 2025

Report

Report Number
MW5171357
Event Type
Malfunction
Date Received
June 11, 2025
Date of Event
May 29, 2025
Report Date
June 9, 2025
Manufacturer
THE MOREL COMPANY
Product Code
FNL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

RECEIVED THE FOLLOWING INFORMATION FROM A HEALTHCARE WORKER: INCIDENT OCCURRED ON (B)(6) 2025 ON NIGHT SHIFT CHANGE. A PATIENT WAS TRANSPORTED TO INPATIENT ROOM. WHEN THE PATIENT CARE ASSISTANT (PCA) WENT INTO THE PATIENT'S ROOM AND PROCEEDED TO DO THE SET OF VITALS, THE PCA FULLY LOWERED THE BED, AND "LOTS OF SPARKS, FIRE, AND A SMOKE CLOUD CAME OUT FROM UNDER THE BED¿. THE PCA IMMEDIATELY UNPLUGGED THE BED FROM THE WALL TO STOP THE SPARKS AND CALLED FOR STAFF ASSISTANCE. THE PATIENT WAS SAFELY REMOVED FROM THE BED WITH NO INJURY. HOSPITAL MAINTENANCE WAS CALLED, AND THE INSULATION OF THE ELECTRICAL HARNESS WAS COMPROMISED AND REMOVED FROM SERVICE. OUR MAINTENANCE DEPARTMENT THEN DID AN INSPECTION OF OTHER BEDS AND FOUND OTHERS THAT WERE COMPROMISED AND REMOVED FROM SERVICE. OUR ORGANIZATION IMMEDIATELY CALLED THE VENDOR AND ON-SITE INSPECTIONS WERE COMPLETED, SAFETY ISSUE WAS IDENTIFIED BY THE VENDOR INVOLVING THE WIRING HARNESS AND A MISSING P CLIP, MOST LIKELY OCCURRING DURING INITIAL INSTALLMENT. VENDOR SENT IN A TEAM OF INSTALLERS ON-SITE, AND THE ENTIRE INVENTORY WAS CHECKED AND REPAIRED, WHEN APPROPRIATE. INVENTORY WAS COMPLETED ON THURSDAY (B)(6) 2025. VENDOR WILL COME BACK IN TO COMPLETE PROACTIVE POST-MARKET SURVEILLANCE (PMS) ON AN MUTUALLY AGREED UPON DALE AND TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
814893 HERCULES PATIENT REPOSITIONER BED, AC-POWERED ADJUSTABLE HOSPITAL FNL THE MOREL COMPANY

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown