FDA Adverse Event Malfunction Summary report: N

4091829

MDR report key: 4091829 · Received July 15, 2014

Report

Report Number: 4091829
Event Type: Malfunction
Date Received: July 15, 2014
Date of Event: July 10, 2014
Report Date: July 15, 2014
Product Problem: Yes
Report Source: User Facility report
Reporter Location: MD, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

DISPOSABLE PAD APPLIED TO THE PATIENT LIFT DEVICE AND WHEN THE PATIENT WAS LIFTED THE PAD RIPPED FROM TOP TO BOTTOM. THE PATIENT WAS SAFELY PLACED ON THE BED TO PREVENT FROM FALLING.====================== MANUFACTURER RESPONSE FOR DISPOSABLE LIFT PAD, HIGHBACK DISPOSABLE SLING (PER SITE REPORTER)======================VOLUNTARY RECALL OF ALL SIMILAR DEVICES THAT HAVE GUIDE LOOPS THAT COULD BE HOOKED IMPROPERLY TO THE LIFT DEVICE. THEY STATED THE PRODUCT WAS NOT DEFECTIVE, BUT IF IMPROPERLY HUNG ON THE LIFT IT COULD TEAR AT THESE LOOPS AS THEY WERE NOT REINFORCED AT THESE AREAS.

Description of Event or Problem · 1

DISPOSABLE PAD APPLIED TO THE PATIENT LIFT DEVICE AND WHEN THE PATIENT WAS LIFTED THE PAD RIPPED FROM TOP TO BOTTOM. THE PATIENT WAS SAFELY PLACED ON THE BED TO PREVENT FROM FALLING.====================== MANUFACTURER RESPONSE FOR DISPOSABLE LIFT PAD, HIGHBACK DISPOSABLE SLING (PER SITE REPORTER)======================VOLUNTARY RECALL OF ALL SIMILAR DEVICES THAT HAVE GUIDE LOOPS THAT COULD BE HOOKED IMPROPERLY TO THE LIFT DEVICE. THEY STATED THE PRODUCT WAS NOT DEFECTIVE, BUT IF IMPROPERLY HUNG ON THE LIFT IT COULD TEAR AT THIS LOOPS AS THEY WERE NOT REINFORCED AT THESE AREAS.

Patients

Seq	Age	Sex	Outcome	Treatment
1	89 YR