FDA Adverse Event Malfunction Summary report: N

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

MDR report key: 3083771 · Received April 29, 2013

Report

Report Number
1031452-2013-00816
Event Type
Malfunction
Date Received
April 29, 2013
Report Date
April 4, 2013
Manufacturer
INVACARE FLORIDA OPERATIONS
Product Code
FNL
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NE, US
Reporter Occupation
MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Description of Event or Problem · 1

(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ALLEGES THE WELD CAME LOOSE ON THE FOOT SPRING. MDR FILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
183289 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

Patients

Seq Age Sex Outcome Treatment
1 Other