BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3941858 · Received June 3, 2014

    Report

    Report Number
    2020362-2014-00206
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 2, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: - RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE. THE ALARM SOUNDS WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD AND IS SILENT WHEN WEIGHT IS APPLIED TO THE SENSOR PAD, AS EXPECTED. HOWEVER, THE ALARM SOUNDS ON AND OFF WHEN THE SENSOR CABLE IS MOVED. THERE IS A CUT ON THE GREEN OVER MOLD AND ALL PINS INSIDE THE SENSOR RECEPTACLE ARE BENT DOWN. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER YET DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. CUSTOMER DID NOT PROVIDE A DATE WHEN THE ISSUE WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324185 KEEPSAFE DELUXE KMI J. T. POSEY COMPANY 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER MATTRESS SENSOR PAD: PART #8307, LOT # UNK