BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3915159 · Received May 15, 2014

    Report

    Report Number
    2020362-2014-00183
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. THE ALARM WAS RECEIVED WITH THE DELAY FEATURE SET AT 2 SECONDS. THE UNIT POWERS UP WITH BATTERIES. THE UNIT SOUNDS WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD AND IS SILENT WHEN WEIGHT IS APPLIED TO THE SENSOR PAD. UNIT WAS TESTED WITH THE RETURNED COMMODE SENSOR PAD AND IT FUNCTIONS PROPERLY. UNIT WAS ALSO TESTED WITH A SENSOR SIMULATOR AND IT FUNCTIONS PROPERLY. THE ALARM PASSED ALL FUNCTIONAL TESTS PERFORMED. HOWEVER, ONE OF THE ALARM BATTERY SPRINGS IS SEVERELY BENT. THE RETURNED SEAT SENSOR PAD WAS TESTED WITH A KNOWN WORKING PN 8361 ALARM AND UNIT SOUNDS WHEN WEIGHT IS REMOVED FROM THE SEAT SENSOR AND IT IS SILENT WHEN THE WEIGHT WAS APPLIED TO THE SEAT SENSOR. THE SEAT SENSOR PASSED ALL FUNCTIONAL TESTS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THE PATIENT GOT UP FROM THE COMMODE, THE ALARM DID NOT SOUND AND THE PATIENT FELL. THE PATIENT SUSTAINED A MINOR ABRASION ON HIS LEFT KNEE. NO SERIOUS INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289579 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR TOILET SEAT SENSOR, MODEL# 8332, LOT #3309D08