BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2924642 · Received December 14, 2012

    Report

    Report Number
    2020362-2012-00677
    Event Type
    Malfunction
    Date Received
    December 14, 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

    EVALUATION CODES: RESULTS: THE REPORTED ISSUE THAT THE ALARM HAS NO POWER WAS NOT CONFIRMED. USER RETURNED A NOTE THAT READS, "DOES NOT DO ANYTHING." ALTHOUGH THE UNIT DID NOT POWER UP WITH THE CUSTOMER'S RETURNED BATTERIES, WHEN USING NEW BATTERIES THE UNIT HAS INTERMITTENT POWER AND IT TURNS ON AND OFF ON ITS OWN. WHEN USING AN EXTERNAL POWER SUPPLY THE UNIT POWERS UP WITH NO INTERMITTENCY. THE ALARM SOUND, AS IT SHOULD. VISUAL OBSERVATIONS NOTED THE TOP RIGHT CORNER OF CASE IS CRACKED, LIQUID LABEL IS MISSING, BATTERY DOOR IS BROKEN, AND HINGE IS MISSING. ADDITIONALLY THE LCD DISPLAY IS NOT LEGIBLE. NOTE: THE INSTRUCTIONS FOR USE HAVE A WARNING STATEMENT: THE POSEY SITTER SELECT IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF, BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE IS CRACKED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS NO POWER. THEY REPLACED THE BATTERIES WITH A NEW SUPPLY. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM REPORTED. 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 OVER-THE-MATTRESS SENSOR PAD: MODEL# 8307, LOT#UNK