BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE CHAIR BELT SENSOR

    MDR report key: 1935704 · Received December 16, 2010

    Report

    Report Number
    2020362-2010-00401
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 19, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT HAVE BEEN REQUESTED TO BE RETURNED, BUT HAVE NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CHAIR BELT ALARMS INTERMITTENTLY AND AT TIMES WHEN THE BUCKLE IS RELEASED THE ALARM WILL NOT SOUND. THEY HAVE TRIED NEW BATTERIES IN THE ALARM. THEY REPORTED THAT THE PT TENDS TO GET FOOD IN THE SENSOR BELT. THIS WAS DISCOVERED WHILE IN USE WITH A PT; HOWEVER, NO PT INCIDENT OR INJURY OCCURRED. MFR REPORT # 2020362-2010-00402 WILL BE SENT FOR THE 8350 ALARM REPORTED ON THIS CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE CHAIR BELT SENSOR KMI J. T. POSEY CO. 8371 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI KEEPSAFE FALL MONITOR MODEL: 8350, SERIAL # UNK