BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQUARE CHAIR SENSOR PAD

    MDR report key: 3132154 · Received May 1, 2013

    Report

    Report Number
    2020362-2013-00199
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 4, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THE RJ11 CONNECTOR CLIP IS FLAT WHICH DOES NOT KEEP THE CONNECTOR SECURE IN THE RECEPTACLE ON THE ALARM. WHEN THE RJ11 CLIP IS MANUALLY HELD IN PLACE, THE SENSOR WORKS AS EXPECTED. NOTE: INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: NEVER JERK OR PULL ON SENSOR CORD TO REMOVE RJ11 PLUG. DOING SO WILL DAMAGE THE CORD OR PLUG AND MAY CAUSE SENSOR TO FAIL. ALWAYS USE PLASTIC TAB TO RELEASE PLUG. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RJ11 CONNECTOR TO THE SENSOR IS BENT WHICH IS NOT ALLOWING THE SENSOR TO PLUG INTO THE ALARM. THE CUSTOMER REPORTED THIS WAS DISCOVERED DURING SET UP BUT DID NOT PROVIDE THE DATE WHEN FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190948 SQUARE CHAIR SENSOR PAD KMI J. T. POSEY CO. 8308 011312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SITTER SELECT MODEL: 8361. SN: UNK