FDA Adverse Event Malfunction Summary report: N

SUNRISE MEDICAL SLING

MDR report key: 28368 · Received August 17, 1994

Report

Report Number
28368
Event Type
Malfunction
Date Received
August 17, 1994
Date of Event
July 13, 1994
Report Date
August 2, 1994
Manufacturer
GUARDIAN PRODUCTS CO, INC.
Product Code
FSA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WA, US
Reporter Occupation
OTHER CAREGIVERS

Narratives

Description of Event or Problem · 1

THE INCIDENT INVOLVED A RESIDENT SLIPPING OUT OF A SLING USED FOR A MECHANICAL LIFTING DEVICE. NO INJURY OCCURRED TO THE RESIDENT, HOWEVER TWO NURSE AIDES WERE INJURED CATCHING THIS RESIDENT TO KEEP HIM FROM FALLING. THIS WAS A NEW SLING, FIRST TIME USED. UPON LIFTING THE RESIDENT BACK TO BED FROM THE WHEELCHAIR, USING THE MECHANICAL LIFT, THE RESIDENT BEGAN TO FALL OUT OF THE SLING. THE AIDES HAD TO MOVE QUICKLY AND UNEXPECTEDLY TO KEEP PT FROM FALLING. THEY HELD HIS WEIGHT, PROTECTING THE RESIDENT. HOWEVER, BOTH EMPLOYEES HAD TO BE RELIEVED OF DUTY THAT DAY TO SEEK MEDICAL CARE. ONE PERSON WAS OFF WORK FOR SEVEN AND ONE-HALF DAYS, AND ONE MISSED ONE AND ONE-HALF DAYS WITH FOUR DAYS OF LIGHT DUTY WORK. UPON EXAMINATION OF THE SLING, IT WAS FOUND THAT THE CLASP WHICH HOOKS TO HOLD THE SLING HAD A MISSING SPRING WHICH RESULTED IN THE CLASP OPENING WHEN PRESSURE WAS EXERTED UPON IT, SUCH AS THE WEIGHT OF THE RESIDENT'S BODY. THE SPRING WAS NEVER FOUND. ANOTHER SLING OF THE SAME BRAND AND MAKE WAS RETURNED TO THE CO FOR A PROBLEM IN WHICH THE CLASP WAS PLACED ON BACKWARDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUNRISE MEDICAL SLING MECHANICAL LIFT SLING FSA GUARDIAN PRODUCTS CO, INC. 309

Patients

Seq Age Sex Outcome Treatment
1 81 YR Other