BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 3866584 · Received April 25, 2014

    Report

    Report Number
    2020362-2014-00159
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    March 24, 2014
    Manufacturer
    J. T. POSEY COMPANY
    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

    PRODUCT HAS BEEN REQUESTED TO BE RETURNED, BUT HAS NOT BEEN RECEIVED. THIS REPORT IS MADE BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. NOT: INSTRUCTIONS FOR USE STATE: IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM OR SENSOR IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR THE PIR SENSOR IS ACTIVATED. (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. CUSTOMER TESTED THE ALARM WITH A DIFFERENT SENSOR AND THE ISSUE CONTINUES. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER STATED THIS WAS DISCOVERED DURING SET UP WHILE CAREGIVER WAS AT BEDSIDE BUT COULD NOT PROVIDE A DATE WHEN FOUND. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250614 POSEY KEEPSAFE DELUXE KMI J. T. POSEY COMPANY 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER-THE-MATTRESS SENSOR PAD: MODEL: 8307 LOT #UNK