BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER SELECT

    MDR report key: 3953494 · Received June 12, 2014

    Report

    Report Number
    2020362-2014-00215
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 15, 2014
    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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE. UNIT DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. THERE ARE SCUFF MARKS ON FRONT AND BACK OF THE ALARM CASE. PIN 1 INSIDE THE SENSOR EXCEPTABLE IS BENT AND CROSSES OVER TO PIN 2, CAUSING THE UNIT TO NOT SEND A SIGNAL TO ACTIVATE THE NURSE CALL FEATURE. ADDITIONALLY, THE UNIT DOES NOT ALARM IN FAILSAFE MODE. PIN 1 BEING BENT IS EVIDENCE OF PHYSICAL DAMAGE WHILE IN USE. NOTE: THERE IS NO EVIDENCE OF A MANUFACTURING NON-CONFORMITY AND THE INSTRUCTIONS FOR USE (IFU) WERE FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED AT THAT TIME. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM ONLY SOUNDS WHEN THE PULL CORD IS DETACHED FROM THE ALARM. CUSTOMER REPORTED WHEN THE ALARM IS IN USE WITH A KNOWN WORKING SENSOR THE ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. ISSUE WAS DISCOVERED DURING SET-UP BUT THE DATE WAS NOT PROVIDED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347821 POSEY SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SQUARE CHAIR SENSOR PAD PART #8305, LOT #UNK