FDA Adverse Event Malfunction Summary report: N

SHOWER CHAIR

MDR report key: 6501 · Received September 15, 1993

Report

Report Number
32574-1993-00005
Event Type
Malfunction
Date Received
September 15, 1993
Report Date
July 22, 1993
Manufacturer
INNOVATIVE PRODUCTS
Product Problem
Yes
Report Source
Distributor report
Reporter Location
IA, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

HARMONY HOUSE NOTIFIED RED LINE MEDICAL SUPPLY, INC. THAT WHILE A PATIENT WAS BEING TRANSFERRED EITHER IN TO OR OUT OF A SHOWER CHAIR, THE PATIENT FELL BACKWARDS AND TRIED TO STABILIZE HIMSELF BY GRABBING THE CHAIR, THEN THE SHOWER CHAIR COLLASPED. THE PATIENT WAS NOT INJURED AND IS FINE. THE NURSING HOME REPORTED THAT THE SHOWER CHAIR INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY INNOVATIVE PRODUCTS. INNOVATIVE PRODUCTS HAS BEEN NOTIFIED OF THIS INCIDENT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: UNKNOWN. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SHOWER CHAIR INNOVATIVE PRODUCTS UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 35 YR Other