BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3904702 · Received May 21, 2014

    Report

    Report Number
    2020362-2014-00202
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. HOWEVER, IF THE SENSOR CABLE IS WIGGLED INSIDE THE RJ-11 RECEPTACLE, UNIT ALARMS INTERMITTENTLY. WHEN THE SENSOR CABLE IS NOT WIGGLED, THE UNIT'S HOLD MODE FEATURE WORKS PROPERLY. VISUAL FINDINGS OBSERVED ONE OF THE BATTERY SPRINGS IS BENT. ALSO ALL OF THE PINS INSIDE THE RJ-11 RECEPTACLE ARE BENT DOWNWARD. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE HOLD BUTTON IS PRESSED THE ALARM BEGINS TO SOUND. THE ISSUE WAS DISCOVERED DURING SETUP, BUT THE DATE OF THE EVENT IS UNK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303520 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MAGNET, MODEL 8361M, LOT # NA