BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2031495 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00071
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    December 16, 2010
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THE BATTERY SPRINGS ARE BENT INSIDE THE BATTERY COMPARTMENT. THE PIN 1 IN THE RJ-11 RECEPTACLE IS LOWER THAN THE REST OF THE PINS. FURTHER INSPECTION FOUND THAT THE ALARM'S SPEAKER IS NOT WORKING PROPERLY. THE ALARM DOES POWER ON AND HAS SOUND WHEN IT SHOULD BUT THE VOLUME IS LOW EVEN WHEN SET TO MAXIMUM VOLUME. THERE IS ADHESIVE RESIDUE ON THE BATTERY CASE. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT THE ALARM SOUNDS VERY LOW WHEN USING THE MAGNET PULL CORD. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS A BAD SPEAKER AND THE BATTERY SPRINGS ARE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI