BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2759915 · Received September 19, 2012

    Report

    Report Number
    2020362-2012-00556
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Report Date
    August 29, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION OF THE RETURNED PRODUCT REVEALED THE UNIT DID NOT POWER UP WITH BATTERIES BECAUSE OF BATTERY LEAKAGE AND CORROSION ON THE FLAT CONTACTS. THE BATTERY LEAKAGE CAUSED THE AQUALERT WATER INDICATOR TO SHOW MOISTURE EXPOSURE. THE UNIT DOES POWER UP WHEN USING AN EXTERNAL POWER SUPPLY OR A 9V ADAPTER AND PASSES ALL FUNCTIONAL 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. DO NOT ALLOW BATTERIES TO DEPLETE WHILE IN THE ALARM. DEPLETED BATTERIES MAY LEAK AND CORRODE, CAUSING DAMAGE TO THE ELECTRONICS AND RELIABILITY.(B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE VOICE MODULE DOES NOT WORK. CUSTOMER ALSO REPORTED THAT HE IS ABLE TO ONLY USE THE TONE. THERE WAS NO PATIENT 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 LOT # UNKNOWN| OVER-THE-MATTRESS SENSOR PAD, MODEL #8307