FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 2211891 · Received August 11, 2011

Report

Report Number
2211891
Event Type
Malfunction
Date Received
August 11, 2011
Date of Event
June 7, 2011
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

PATIENT WAS PLACED IN SHOWER CHAIR IN BATHROOM. SHORTLY AFTER SITTING ON SHOWER CHAIR, ONE OF THE LEGS BUCKLED UNDER THE PATIENT'S WEIGHT ALLOWING HIM TO FALL TO FLOOR. HE WAS A RECENT LEFT KNEE REVISION AND THE FALL CAUSED HIS KNEE TO BLEED REQUIRING A PRESSURE DRESSING APPLICATION AND ICE. PHYSICIAN WAS NOTIFIED, SAW PATIENT AND EXTENDED HIS STAY ONE MORE DAY FOR OBSERVATION. HE DID FINE AND WAS DISCHARGED THE FOLLOWING DAY.WE DO HAVE A FEW CHAIRS AVAILABLE FOR HEAVIER PATIENTS, BUT NOT ENOUGH TO HANDLE THE NEED. AS A RESULT OF THESE EVENTS, WE HAVE DEVELOPED A COMMITTEE TO LOOK AT ALTERNATIVES WHICH INCLUDES BUYING MORE "BARIATRIC STYLE" CHAIRS. WE ARE FINDING MANY OF OUR PATIENTS TO BE CLOSE TO OR JUST OVER THE WEIGHT LIMIT. ALSO, EDUCATION IS FORTHCOMING TO STAFF REGARDING REMINDER MESSAGES THAT THEY SHOULD CONVEY TO PATIENTS ON SAFE USE OF EQUIPMENT. NO CROSSBARS NOTED ON CHAIRS TO HELP WITH RE-ENFORCEMENT FOR WEIGHT DISTRIBUTION. THE BARIATRIC STYLE CHAIRS HAVE CROSSBARS TO ASSIST. WE FIND THAT MOST EQUIPMENT HAS A WEIGHT CAPACITY, BUT IT IS NOT CONSISTENT. EMPLOYEES ARE HAVING A TOUGH TIME MEMORIZING WHAT WEIGHT RESTRICTION GOES WITH WHAT PIECE OF EQUIPMENT. WE ALSO NOTED THAT THESE CHAIRS HAVE A LABEL ATTACHED THAT LISTS THE WEIGHT CAPACITY, BUT ITS LOCATION IS UNDER THE SEAT. WE WONDER WHY THEY DON'T PLACE THAT LABEL IN AN EASY TO SEE LOCATION SO THAT THOSE USING THE EQUIPMENT CAN SEE IT CLEARLY AND NOT HAVE TO "HUNT AND SEARCH FOR IT."

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 59 YR NO OTHER THERAPIES