FDA Adverse Event Death Summary report: N

SAF-LIFT

MDR report key: 1253 · Received August 26, 1992

Report

Report Number: 1253
Event Type: Death
Date Received: August 26, 1992
Date of Event: July 21, 1992
Report Date: July 31, 1992
Manufacturer: CENTURY MFG. COMPANY
Product Code: ILJ
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON 7/21/92 ONE OF OUR RESIDENTS SUFFERED A FRACTURED HIP INVOLVING THE BAR HOOK STYLE SAF-LIFT. THE RESIDENT EXPIRED ON 7/29/92 AS A CAUSE OF DEATH BEING ASYTOLE. UPON INVESTIGATION I DISCOVERED THAT THE SAFETY BAR DID NOT LOCK PROPERLY WHEN THE CHAIR WAS PLACED IN THE LIFT; AND EITH THE MOVEMENT OF THE RESIDENT LEANING FORWARD AS THE CERTIFIED NURSING ASSISTANT WAS LIFTING THE RESIDENT'S LEGS UPWARD CAUSED THE CHAIR TO DISMOUNT THE LIFTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SAF-LIFT	TUB-LIFT	ILJ	CENTURY MFG. COMPANY

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death