FDA Adverse Event Death Summary report: N

NA

MDR report key: 26385 · Received August 26, 1995

Report

Report Number
26385
Event Type
Death
Date Received
August 26, 1995
Date of Event
August 12, 1995
Report Date
August 22, 1995
Manufacturer
LAGUNA HONDA HOSPITAL
Product Code
FSA
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

DURING TRANSFER FROM WHEELCHAIR TO TOILET STALL, WIDE STRAPS OF TRANSFER BELT ON LIFT BROKE, CAUSING THE PT TO FALL, HITTING HER HEAD ON THE FLOOR. IT WAS DETERMINNED THAT THE STITCHES THAT HOLD THE RING OF THE BELT, OR STRAPS, BROKE. THE PT SUSTAINED A R. PARIETAL SCALP LACERATION REQUIRING SUTURING. THE PT DIED THE NEXT MORNING AND THE CASE WAS ACCEPTED BY THE CORONER'S OFFICE. THE LIFT THAT BROKE WAS NOT A MFR'S STRAP, BUT WAS MADE BY THE HOSP'S SEWING DEPT. IT APPEARED THAT THE FOLDED OVER, REINFORCED PART OF THE STRAP WAS TOO SHORT, AND SHOULD HAVE BEEN SEVERAL INCHES LONGER, WITH REINFORCED STITCHING.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, INADEQUATE QUALITY ASSURANCE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NA WIDE PADDED STRAPS FOR USE WITH HOYER LIFT FSA LAGUNA HONDA HOSPITAL NA NA

Patients

Seq Age Sex Outcome Treatment
1 87 YR Death