BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 2031493 · Received March 18, 2011

    Report

    Report Number
    2020362-2011-00072
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    December 30, 2011
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE POWER WAS INTERMITTENT DURING EVALUATION WHEN USING NEW BATTERIES. THERE IS NO VISIBLE DAMAGE TO THE ALARM. MANUFACTURER REFERENCES FILE # (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES. NO SIGNS OF ANY PHYSICAL DAMAGE TO THE ALARM CASE. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS INTERMITTENT POWER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA