BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2820558 · Received October 4, 2012

    Report

    Report Number
    2020362-2012-00577
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 6, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE THERE IS SOUND WHEN WEIGHT IS REMOVED FROM SENSOR. IF UNIT IS SET TO VOICE OR VOICE AND TONE THE MESSAGE BEGINS TO PLAY BUT UNIT POWERS OFF ON ITS OWN AFTER A COUPLE OF SECONDS. UNIT POWERS BACK UP ON ITS OWN AFTER WEIGHT IS PLACED BACK ON SENSOR. CUSTOM RECORDING PLAYS BACK BUT UNIT TURNS OFF AFTER A COUPLE OF SECONDS. LOW BATTERY INDICATOR SOUNDED ONCE THEN UNIT TURNED OFF ON ITS OWN AND WOULD NOT POWER BACK UP. UNIT PASSED ALL OTHER FUNCTIONAL TESTS. THE PRODUCT CONDITION SHOWS THE PLASTIC FILM OVER THE BATTERY DIAGRAM IS PEELING. CASE IS CRACKED AROUND THE BATTERY COMPARTMENT. BATTERY SPRINGS ARE BENT. NOTE: THE INSTRUCTIONS FOR USE HAS 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. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT UNATTENDED. IF THE ALARM AND/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 THE FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM WILL NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE CUSTOMER REPORTED THE ALARM WAS TESTED WITH NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM REPORTED. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS OCCURRED. THE ISSUE WAS DISCOVERED WHILE IN USE WITH A PATIENT BUT THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    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 UNK OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT #UNK