BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1935724 · Received December 16, 2010

    Report

    Report Number
    2020362-2010-00402
    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 HAS BEEN REQUESTED FOR RETURN BUT HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM SOUNDS INTERMITTENTLY WHEN THE SENSOR BELT IS RELEASED. THE CUSTOMER REPORTED THAT THERE WAS NO VISIBLE DAMAGE TO THE ALARM UNIT. THIS WAS DISCOVERED WHILE IN USE WITH A PT BUT NO INCIDENT OR INJURY OCCURRED. MFR REPORT # 2020362-2010-00401 FOR THE SENSOR BELT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI MOBILE CHAIR BELT SENSOR: MODEL 8371, LOT # UNK