BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 2112443 · Received March 22, 2011

    Report

    Report Number
    1525965-2011-00018
    Date Received
    March 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS ON-GOING AND A FOLLOW-UP MDR WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT THAT ALLEGED THAT THE RESPIRATORY BELT IS TEARING LOOSE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC 728246

    Patients

    Seq Age Sex Outcome Treatment
    1