FDA Adverse Event Death Summary report: N

SAF LIFT

MDR report key: 7724 · Received November 5, 1993

Report

Report Number
7724
Event Type
Death
Date Received
November 5, 1993
Date of Event
October 27, 1993
Report Date
November 2, 1993
Manufacturer
CENTURY MFG. CO.
Product Code
FSA
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON 10/27/93, AT APPROX 9:45 AM, A RESIDENT WAS PREPARED OR ASSISTED BY THE NURSE AIDES IN PREPARATION FOR THIS PERSONS WHIRLPOOL. THE TWO AIDES ASSISTING THE RESIDENT IN THE ROOM UNDRESSED THE RESIDENT, PUT THE RESIDENT IN A LOW BACK CHAIR, AND SECURED THE SAFETY BELT. THE AIDE ASSIGNED TO GIVE THE RESIDENT THE WHIRLPOOL, GAVE THE RESIDENT THE WHIRLPOOL AND TOOK THE RESIDENT OUT OF THE WHIRLPOOL. AS THE AIDE WAS LOWERING THE RESIDENT, THE RESIDENT LEANED FORWARD AND STARTED TO FALL. THE AIDE TRIED TO BREAK THE FALL BUT FELL WITH RESIDENT TO THE FLOOR. THE RESIDENT HIT FACE FIRST ON THE FLOOR. THE SAFETY BELT WAS COMPLETELY LOSE AND OFF THE RESIDENT. THE RESIDENT WAS TRANSFERED TO THE HOSP BY AMBULANCE AND SUFFERED SEVERAL FACIAL INJURIES. THE RESIDENT DIED 10/28/93, CAUSE OF DEATH UNKNOWN AT THIS TIME OF THE REPORT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-93. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INSERVICED BY OTHER FACILITY STAFF, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SAF LIFT UNKNOWN FSA CENTURY MFG. CO. SL-10 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 84 YR Death