BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 3253646 · Received July 17, 2013

    Report

    Report Number
    2020362-2013-00321
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    May 10, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; THE POWER AND HOLD BUTTONS ARE NOT MISSING BUT DO HAVE SIGNS OF DAMAGE TO THEM. HOWEVER, THE ALARM POWERS ON AND WHILE TESTING THE LOW BATTERY FUNCTION, THE ALARM LOST POWER. THE LOW BATTERY LED LIGHT IS FAINT. RE-INSTALLED THE BATTERIES AND THE UNIT HAS POWER BUT THE TONE AND VOICE HAS A STATIC SOUND. THE SCREWS ON THE BACK OF THE ALARM CASE HAVE RUST ON THEM. MORE INFO RECEIVED IS THE VOLTAGE REGULATOR IS LOW. NOTE: THE INSTRUCTIONS FOR USE STATE: THE LOW BATTERY LIGHT WILL FLASH RED WHEN NEW BATTERIES ARE NEEDED. CHANGE BATTERIES AT ONCE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE POWER BUTTON IS MISSING ON THE ALARM. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331802 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

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