BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPIRATION ELITE

    MDR report key: 2573840 · Received May 7, 2012

    Report

    Report Number
    2243193-2012-00004
    Event Type
    Other
    Date Received
    May 7, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 1, 2012
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K042655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESPIRONICS WILL CONTINUE TO MONITOR FOR RELATED ISSUES.

    Description of Event or Problem · 1

    UNIT DID NOT TURN ON AND, AS A RESULT, THE NEBULIZER DID NOT RECEIVE AIR FROM THE COMPRESSOR WITH WHICH TO POWER THE NEBULIZER TO GENERATE AEROSOL. THIS PRODUCT FAILURE CAUSED THE PATIENT TO GO TO THE HOSPITAL FOR TREATMENT OF HIS ASTHMA. RESPIRONICS BELIEVES THIS TO BE AN ISOLATED INCIDENT AS COMPLAINT LEVELS FOR ALL COMPLAINTS FOR THIS PRODUCT LINE ARE BELOW (B)(4) OF ANNUAL SALES. HOWEVER, RESPIRONICS WILL CONTINUE TO MONITOR FOR THIS SPECIFIC ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION ELITE INSPIRATION ELITE CAF RESPIRONICS NEW JERSEY, INC. HS456 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization