BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2490603 · Received March 6, 2012

    Report

    Report Number
    2020362-2012-00141
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Report Date
    January 19, 2012
    Manufacturer
    J. T. POSEY COMPANY
    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

    (B)(4). RESULTS: EVAL OF THE RETURNED PRODUCT REVEALED THE DELAY SWITCH WAS SET AT 4 SECONDS. THE UNIT DID NOT POWER UP WHEN TESTED WITH BATTERIES OR AN EXTERNAL POWER SUPPLY. ALSO THE BATTERY SPRINGS ARE BENT AND THE UNIT LABEL IS DAMAGED. POSEY INSTRUCTIONS FOR USE WARNING STATEMENT: THE SITTER SELECT IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED OR IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED FOR USE. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS NO POWER. THE ALARM WAS TESTED WITH NEW BATTERIES. THE ALARM DOOR CLOSES PROPERLY. THE BATTERY CONTACTS ARE INTACT. NO CRACKS ON THE CASE WERE DETECTED BY THE CUSTOMER. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SITTER SELECT MAGNET: MODEL # 8361M, LOT # UNK