BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVER-THE-MATTRESS SENSOR PAD

    MDR report key: 2241305 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00301
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 5, 2011
    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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD THERE IS NO ALARM TONE. THE CUSTOMER REPORTED THAT THEY TESTED THE SENSOR PAD WITH ANOTHER WORKING ALARM AND THE RESULTS REMAINED THE SAME. THERE WAS NO DAMAGE NOTED TO THE RJ11 CLIP OR CREASES ON THE SENSOR PAD. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER-THE-MATTRESS SENSOR PAD KMI J. T. POSEY CO. 8307 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA