BEUDAMED
    FDA Adverse Event Death Summary report: N

    GTM CHAIR

    MDR report key: 2905956 · Received January 4, 2013

    Report

    Report Number
    9681684-2012-00101
    Event Type
    Death
    Date Received
    January 4, 2013
    Date of Event
    March 3, 2011
    Report Date
    December 6, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    INM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE (B)(4). AN ARJOHUNTLEIGH REPRESENTATIVE WAS MADE AWARE OF THE INCIDENT BECAUSE OF THE BROADCASTING OF THIS NEWS REPORT ON A PROVINCIAL CHANNEL OF TELEVISION NEWS. HE THEN ATTEMPTED TO CONTACT THE FACILITY TO OBTAIN MORE DETAILS IN ORDER TO PROCEED WITH THE INVESTIGATION, BUT THE ONLY INFORMATION RELEASED WAS THE BRAND NAME AND MODEL OF THE CHAIR. THE FACILITY REFUSED TO PROVIDE MORE DETAILS ON THE INCIDENT DUE TO ON-GOING LEGAL PROCEDURES. THE DESIGNATED COMPLAINT HANDLING UNIT (DCHU) PERFORMED AN INVESTIGATION WITH THE INFORMATION AVAILABLE. A REVIEW OF THE TREND FOR EVENTS WITH THIS DEVICE DID NOT PERMIT TO FIND ANOTHER OCCURRENCE. THIS IS CONSIDERED TO BE AN ISOLATED CASE. SINCE THE SERIAL NUMBER WAS NOT AVAILABLE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THIS PRODUCT IS NO LONGER MANUFACTURED. THERE WERE NO FIELD ACTIONS ASSOCIATED WITH THIS PRODUCT OR RELEVANT TECHNICAL BULLETIN. IT WAS INDICATED IN THE NEWS REPORT THAT A STRAP WOULD HAVE GIVEN MAY DURING THE BATHING ACTIVITY. THE CHAIR INCORPORATES THREE SAFETY STRAPS WITH BUCKLES, WHICH RETAIN THE RESIDENT IN THE SEAT. THIS TYPE OF CHAIR REQUIRES A CEILING LIFT IN ORDER TO ACCESS THE BATH, SINCE THE CEILING LIFT HOOKS TO A MAST ABOVE THE CHAIR, WHICH LIFTS THE SEAT OF THE CHAIR. IT IS UNK WHICH STRAP WAS REPORTED TO HAVE GIVEN WAY DURING THE EVENT SINCE THE FACILITY DID NOT PROVIDE SUCH INFORMATION. IT COULD BE ONE OR MORE OF THE SAFETY STRAP WITH BUCKLES, OR IT COULD BE THE STRAP OF THE CEILING LIFT. BASED ON THE LACK OF INFORMATION, THE DCHU CANNOT GO FURTHER WITH THE INVESTIGATION PROCESS AND THE ROOT CAUSE ANALYSIS. IT MUST BE NOTED THAT THE STRAPS HAVE AN EXPECTED LIFETIME OF TWO YEARS, AND THEIR INSPECTION IS REQUIRED PRIOR TO EACH USE AS PER THE PREVENTIVE MAINTENANCE CHECKLIST (B)(4). WITH THE INFORMATION PROVIDED, NO RECOMMENDATION CAN BE ISSUED TO THE FACILITY. SHOULD ANY NEW INFORMATION BE RECEIVED, THIS FILE COULD BE RE-OPENED TO EVALUATES AS PER INTERNAL INVESTIGATION PROCESS.

    Description of Event or Problem · 1

    THE SINGLE STAFF MEMBER WAS USING A CHAIR TO BATH A RESIDENT. WHILE HE WAS BEING BATHING, HE LEANED FORWARD AND MADE A FALL OF 2 METERS IN THE TUB, STRIKING HIS HEAD. IT WAS REPORTED THAT THE SAFETY STRAP OF THE CHAIR WOULD HAVE GIVEN WAY. THE RESIDENT DID NOT IMMEDIATELY COMPLAIN OF PAIN AFTER THE FALL AND WAS BROUGHT BACK TO HIS BED. LATER, HE QUICKLY COMPLAINED OF STRONG HEADACHES, WAS ADMITTED TO HOSPITAL TO SEE A DOCTOR TWO DAYS AFTER THE EVENT, WHERE A CERVICAL FRACTURE WAS DIAGNOSED. HE DECEASED FEW WEEKS LATER OF MULTIPLE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4508 GTM CHAIR NONE INM ARJOHUNTLEIGH MAGOG INC. 6050

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death