BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2920273 · Received December 17, 2012

    Report

    Report Number
    2020362-2012-00684
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Report Date
    November 14, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE THAT THE UNIT HAS NO POWER. THE UNIT POWERS UP, BUT WHEN SET TO VOICE OR VOICE AND TONE THERE IS NO SOUND WHEN WEIGHT IS OFF THE SENSOR PAD OR WHEN THE PAD IS DETACHED. THERE IS NO PHYSICAL DAMAGE TO THE UNIT. ADDITIONAL TESTS PERFORMED REVEALED NO PRODUCT PROBLEM THE UNIT PASSES ALL TESTS. NOTE: POSEY INSTRUCTIONS FOR USE WARNING STATEMENT: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES. AFTER CHANGING BATTERIES, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY HAVE HAD THE UNIT FOR A WEEK AND IT WILL NOT POWER ON. THEY HAVE REPLACED THE BATTERIES WITH A NEW SUPPLY. THERE ARE NO SIGNS OF BATTERY CORROSION OR BATTERY LEAKAGE ON THE BATTERY COMPARTMENT. NO OTHER PHYSICAL DAMAGE WAS REPORTED BY THE CUSTOMER. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

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