BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2914852 · Received December 7, 2012

    Report

    Report Number
    2020362-2012-00675
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 26, 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: EVAL OF THE RETURNED PRODUCT FOUND THE REPORTED ISSUE IS CONFIRMED. THE UNIT POWERS UP BUT THERE IS NO SOUND WHEN WEIGHT IS REMOVED FROM SENSOR. NO SOUND WHEN SENSOR IS DETACHED. USED A KNOWN WORKING SENSOR. LOW BATTERY LED LENS IS PUSHED INTO THE CASE. NURSE CALL AND LOW BATTERY FUNCTIONS WORK AS THEY SHOULD. NO OTHER TESTS CAN BE PERFORMED SINCE THERE IS NO SOUND. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN WEIGHT IS RELEASED FROM THE SENSOR AND THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THE CUSTOMER REPORTED THAT THIS WAS DISCOVERED DURING USE. HOWEVER, THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS OCCURRED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

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