BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE FALL MONITOR

    MDR report key: 1893985 · Received November 3, 2010

    Report

    Report Number
    2020362-2010-00329
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    September 21, 2010
    Manufacturer
    DONGGUAN POSEY MEDICAL DEVICE LTD.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM POWERS ON, BUT THERE IS NO ALARM TONE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT SPECIFY THE REASON FOR THE RETURN OF THE PRODUCT. THERE WAS NO PATIENT INCIDENT OR INJURY. MORE INFORMATION RECEIVED ON THE ALARM STATES "NO SOUND". INSPECTION OF THE PRODUCT SHOWS ALARM POWERS ON, BUT THERE IS NO TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KEEPSAFE FALL MONITOR KMI DONGGUAN POSEY MEDICAL DEVICE LTD. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SQUARE CHAIR SENSOR PAD, MODEL: 8308, LOT NUM: UNK