FDA Adverse Event Malfunction Summary report: N

CARE GUARD SHOWER CHAIR WITH BACK

MDR report key: 2211812 · Received August 11, 2011

Report

Report Number
2211812
Event Type
Malfunction
Date Received
August 11, 2011
Date of Event
November 20, 2010
Report Date
August 11, 2011
Manufacturer
INVACARE
Product Code
INM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US

Narratives

Description of Event or Problem · 1

THE PATIENT WAS USING THE SHOWER CHAIR. HE REACHED FORWARD TO SOAP HIS LEGS AND THE CHAIR TIPPED OVER. HE HIT HIS HEAD AND REQUIRED SUTURING. NO FURTHER TREATMENT WAS NEEDED. STAFF LATER MENTIONED THAT THE CHAIR HAD BEEN WOBBLY AND THAT THE SHOWER FLOOR WAS UNEVEN SO THIS FALL SHOULD HAVE BEEN AVOIDABLE.THE PATIENT WAS BEING EVALUATED TO SEE IF HE WAS SAFE TO RETURN HOME WITH HIS SON. HE IS INDEPENDENT AND DID NOT LIKE FOLLOWING INSTRUCTIONS GIVEN TO HIM. HE WAS ASKED TO SIT IN CHAIR IN SHOWER TO CLEAN UP AND NOT LEAN FORWARD IN CHAIR. HE WAS LEANING FORWARD AND DOWN IN CHAIR TO WASH HIS LEGS. IN THIS PARTICULAR INCIDENT, INSPECTION OF THE CHAIR WAS NOT POSSIBLE. SHORTLY AFTER THE FALL, THE EMPLOYEE STARTED CHECKING THE CHAIR AND TOUCHING BOLTS, ETC WHICH MADE IT IMPOSSIBLE TO KNOW IF ANYTHING WAS LOOSE ON THE CHAIR. THE EMPLOYEE MENTIONED THAT IN RETROSPECT THE CHAIR WAS MAYBE WOBBLY, BUT WE COULD NOT VERIFY THIS SINCE THE CHAIRS BOLTS HAD BEEN TAMPERED WITH PRIOR TO THE REPORT BEING FILED. IN NO WAY ARE WE BLAMING THE PATIENT; JUST STATING THAT THE PATIENT'S LIMITED CAPACITY TO FOLLOW DIRECTIONS FACTORED INTO THE EVENT.AFTER THE DEVICE BEING LOOKED AT AND THEN SENT TO RISK MANAGEMENT DEPARTMENT, IT WAS DISCARDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CARE GUARD SHOWER CHAIR WITH BACK SHOWER CHAIR INM INVACARE * *

Patients

Seq Age Sex Outcome Treatment
1 59 YR NO OTHER THERAPIES