FDA Adverse Event Injury Summary report: N

VERSACARE

MDR report key: 1802569 · Received August 10, 2010

Report

Report Number
1824206-2010-09256
Event Type
Injury
Date Received
August 10, 2010
Date of Event
July 4, 2010
Report Date
July 16, 2010
Manufacturer
HILL-ROM, INC.
Product Code
FNL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE TECH SPOKE WITH THE ACCOUNT WHO STATED, THE PATIENT WAS FOUND ON THE FLOOR BY A DOCTOR. THEY CHECKED THE PATIENT OUT AND PLACED THE PT BACK IN BED. THE NURSE STATED THAT SHE ATTEMPTED TO SET THE BED EXIT BUT BELIEVES THAT SHE DID IT INCORRECTLY. THE ACCOUNT COULD NOT PROVIDE A SERIAL NUMBER AND WOULD NOT MAKE THE BED AVAILABLE FOR THE TECH TO INSPECT. THE ACCOUNT STATED THEY FELT THIS ISSUE WAS CAUSED BY USER ERROR. NO ADD'L INFO REGARDING THE INJURY WAS PROVIDED BY THE ACCOUNT.

Description of Event or Problem · 1

THE ACCOUNT ALLEGED THAT ON (B)(6), 2010, A PATIENT FELL AND BROKE THEIR HIP. THE BED WAS BEING USED IN ACUTE CARE, THE PT WEIGHTED (B)(6) AND THE PT POSITIONING MONITOR WAS ARMED. AN ENVISION MATTRESS WAS BEING USED ON THE BED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VERSACARE AC POWERED HOSPITAL BED FNL HILL-ROM, INC. 3200

Patients

Seq Age Sex Outcome Treatment
1 UNK