FDA Adverse Event Malfunction Summary report: N

CENTURY TUB (WHIRLPOOL) LIFT

MDR report key: 2516 · Received February 8, 1993

Report

Report Number
2516
Event Type
Malfunction
Date Received
February 8, 1993
Date of Event
January 12, 1993
Report Date
January 18, 1993
Manufacturer
CENTURY MANUFACTURING CO.
Product Code
ILJ
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

ON JANUARY 12, 1993 RESIDENT WAS BEING LIFTED INTO WHIRLPOOL FOR BATH WHEN CHAIR BECAME DETACHED FROM LIFT. THE CHAIR FELL TO THE FLOOR WITH RESIDENT STILL IN CHAIR WITH SEAT BELT ON. BATH AIDE BROKE THE FALL AND WS ABLE TO KEEP RESIDENT FROM HITTING HEAD. VITALS AND RANGE OF MOTION WAS PERFORMED BY NURSING STAFF, NO INJURY WAS DETECTED. RESIDENT WAS TRANSFERRED TO HOSPITAL FOR EVALUATION LATER THAT EVENING WHEN SHE DEMONSTRATED A CHANGE IN BEHAVIOR. UPON X-RAY THEY DETECTED NO INJURIES BUT HELD HER OVERNIGHT TO OBSERVE FOR ALTERED MENTALA STATUS. A CT SCAN WAS PERFORMED ON JANUARY 13. 1993 WHICH REVEALED A TIA. RESIDENT WAS ADMITTED TOTHE HOSPITAL. LIFT WAS CHECKED OUT THROUGHLY BUT FAILURE COULD NOT BE DUPLICATED. INCIDENT WAS REPORTED BY PHONE TO MFG. ON 1/13/93DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, CONNECTOR OR ADAPTOR. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CENTURY TUB (WHIRLPOOL) LIFT N/A ILJ CENTURY MANUFACTURING CO. SL-10 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 82 YR Other