BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER SWITCH

    MDR report key: 3001716 · Received March 8, 2013

    Report

    Report Number
    2020362-2013-00069
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    January 22, 2013
    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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE CUSTOMER REPORTED THAT WHEN THE HOSP PERSONNEL ATTEMPTED TO CHANGE THE BATTERIES HE RECEIVED A SHOCK. THERE WAS NO SERIOUS INJURY REPORTED. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99453 KEEPSAFE DELUXE NO POWER SWITCH KMI J. T. POSEY CO. 8374NP NA

    Patients

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