BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 3040601 · Received March 12, 2013

    Report

    Report Number
    2020362-2013-00107
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 15, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE ALARM POWERS ON BUT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR OR WHEN THE SENSOR IS DETACHED FROM THE ALARM (FAIL SAFE). THE TONE SELECTOR AND LOW BATTERY INDICATOR DID NOT SOUND. THE BATTERY DOOR COVER IS MISSING AND THE RJ11 RECEPTACLE IS LIFTED OFF THE PCB. NOTE: INSTRUCTIONS FOR USE STATE: PROPER HANDLING AND USE: IF THE POSEY KEEPSAFE IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AS DESIGNED. VISUALLY INSPECT THE UNIT FOR CRACKS IN THE CASE, MISSING SCREWS, MISSING BATTERY DOOR, BROKEN WIRES OR SIGNS OF EXPOSURE TO LIQUID. AFTER EACH INCIDENT, YOU MUST VERIFY THAT THE UNIT IS WORKING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY AND THERE WAS NO VISIBLE DAMAGE REPORTED. THE CUSTOMER REPORTED THIS WAS DISCOVERED DURING SET-UP BUT COULDN¿T PROVIDE THE DATE WHEN THIS WAS FOUND. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104498 POSEY KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

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