BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE FALL MONITOR

    MDR report key: 3040570 · Received March 12, 2013

    Report

    Report Number
    2020362-2013-00113
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE: THIS REPORT IS SUBMITTED BASED ON THE CUSTOMER'S REPORTED ISSUE STATEMENT. NOTE: POSEY INSTRUCTIONS FOR USE STATES: TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. 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, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, THE PIR SENSOR IS ACTIVATED, OR MAGNET IS REMOVED FROM FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER, BUT WILL NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104429 KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BED SENSOR PAD: MODEL 8307, LOT NUMBER UNK