FDA Adverse Event Malfunction Summary report: N

3002

MDR report key: 2930060 · Received January 24, 2013

Report

Report Number
2930060
Event Type
Malfunction
Date Received
January 24, 2013
Date of Event
January 2, 2013
Report Date
January 24, 2013
Manufacturer
STRYKER
Product Code
FNL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN, US

Narratives

Description of Event or Problem · 1

THE PATIENT WAS BEING DISCHARGED TO HOME. STAFF WAS TRANSFERRING PATIENT FROM BED TO WHEELCHAIR AND FOOT END OF BED ROLLED. BRAKES WERE ON, BUT WHEN PATIENT PUSHED ON THE BED IT MOVED RESULTING IN PATIENT BEING LOWERED TO FLOOR. NO PATIENT INJURY. THE PATIENT DENIES ANY PAIN OR DISTRESS. THE PATIENT'S DOCTOR WAS NOTIFIED AND THE PATIENT WAS DISCHARGED. THE BED WAS TAGGED AND CHECKED BY BIOMED WHERE THE COMPLAINT WAS CONFIRMED. OTHER SECURE 2 BEDS WERE CHECKED AND EXHIBITED THE SAME ISSUE. STRYKER WAS NOTIFIED AND THE SERVICE REPRESENTATIVE VISITED TO CONFIRM THE PROBLEM. SERVICE REPRESENTATIVE INFORMED BIOMED OF A RECALL ISSUED IN MARCH 2012. THE FACILITY DID NOT RECEIVE THIS DEVICE ALERT. SERVICE REPRESENTATIVE RETURNED A FEW DAYS LATER AND REPLACED THE BRAKE PLATE KIT ON THIS BED. THE BED WAS TESTED AND RETURNED TO SERVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
34677 3002 BED, HYDRAULIC, ADJUSTABLE HOSPITAL FNL STRYKER SECURE 2 *

Patients

Seq Age Sex Outcome Treatment
1 46 YR NO OTHER THERAPIES