BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SEAT BELT SENSOR

    MDR report key: 1821293 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00197
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    July 13, 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): EVAL: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE SENSOR BELT ALARMS INTERMITTENTLY WHEN THE BUCKLE IS DETACHED. THERE IS A STRONG SMELL OF URINE ON THE BELT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT SPECIFY THE NATURE OF THE PROBLEM BUT REPORTED THAT THE PRODUCT ISSUE WAS DISCOVERED DURING SETUP, AND THERE WAS NO PT/CAREGIVER INCIDENT OR INJURY REPORTED. INSPECTION OF THE PRODUCT FOUND THAT THE ALARM TONE IS INTERMITTENT WHEN THE BUCKLE IS DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY SEAT BELT SENSOR KMI DONGGUAN POSEY MEDICAL DEVICE LTD. 8360 M1006

    Patients

    Seq Age Sex Outcome Treatment
    1 NI