FDA Adverse Event Malfunction Summary report: N

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

MDR report key: 4120328 · Received September 26, 2014

Report

Report Number
1031452-2014-11002
Event Type
Malfunction
Date Received
September 26, 2014
Date of Event
June 25, 2014
Report Date
June 26, 2014
Manufacturer
INVACARE FLORIDA OPERATIONS
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

CONSUMER STATES WHEN HE WAS INSPECTING THE BED HE NOTICED A CABLE IN THE HEAD SECTION OF THE BED WAS VERY FRAYED AND HAD BROKEN WIRES. NO ADDITIONAL INFORMATION PROVIDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
601656 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410LOW

Patients

Seq Age Sex Outcome Treatment
1 Other