FDA Adverse Event Malfunction Summary report: N

HIGH BACK WHIELPOOL CHAIR THAT GOES IT CONTURY SAT-LIFT

MDR report key: 3643 · Received January 21, 1993

Report

Report Number: 3643
Event Type: Malfunction
Date Received: January 21, 1993
Date of Event: October 4, 1992
Report Date: October 10, 1992
Manufacturer: CENTURY
Product Code: HTE
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

RESIDENT WAS PLACED IN WHIRLPOOL CHAIR AND CHAIR WAS ATTACHED TO LIFT. AS LIFT BEGAN TO RAISE CHAIR, CHAIR TIPPED OVER & RESIDENT FELL ON THE FLOOR STILL STOPPED TO THE CHAIR.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. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, MODIFICATION OF DEVICE - BY USER. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		HIGH BACK WHIELPOOL CHAIR THAT GOES IT CONTURY SAT-LIFT	HTE	CENTURY

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other