BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELITE

    MDR report key: 3063835 · Received April 3, 2013

    Report

    Report Number
    2020362-2013-00146
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 11, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. EVALUATION REVEALED THAT THE ALARM DOES NOT SOUND WHEN THE MAGNET IS REMOVED FROM THE MAGNET PLATE AND NO SENSOR IS ATTACHED. THE CUSTOMER'S RETURNED MAGNET WAS TESTED WITH A KNOWN WORKING MODEL 8345 AND WORKS AS IT SHOULD. THE FAIL SAFE FEATURE DID NOT SOUND WHEN TESTED. HOWEVER, THE ALARM DOES SOUND WHEN USING A WORKING SENSOR AND WEIGHT IS REMOVED FROM PAD. NOTE: INSTRUCTIONS FOR USE WARNING: THE POSEY SITTER ELITE IS AN ELECTRONIC DEVICE. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SVC WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. IF THE ALARM/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, THE PIR SENSOR IS ACTIVATED, OR MAGNET IS REMOVED FROM FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ALARM HAS POWER. HOWEVER, WHEN THE MAGNET PULL CORD IS DETACHED FROM THE ALARM IT WILL NOT SOUND. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THERE IS NOT VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. CUSTOMER DID NOT PROVIDE A DATE WHEN THE ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135411 POSEY SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAGNET: MODEL 8345M, LOT #UNK