BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 2071364 · Received April 21, 2011

    Report

    Report Number
    MW5020368
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 12, 2011
    Manufacturer
    RESPIRONICS
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT FAILED, WHILE IN USE, ON A PT. POWERED DOWN, FAILING TO DELIVER AUGMENTED BREATH TO A PT. THE MACHINE IS USED IN CONJUNCTION WITH TUBING AND A MASK. ONCE THE MACHINE FAILED THE MASK WAS REMOVED NEARLY SIMULTANEOUSLY. THE ALARM DID SOUND, AND THERE WAS NO APPARENT ADVERSE OUTCOME. DATES OF USE: (B)(6) INTERMITTENTLY. DIAGNOSIS OR REASON FOR USE: RESPIRATORY INSUFFICIENCY, CYSTIC FIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS VISION MNT RESPIRONICS 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening