BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO

    MDR report key: 12347157 · Received August 20, 2021

    Report

    Report Number
    2518422-2021-03352
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 3, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030213
    PMA / PMN Number
    K113068
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. THIS ACTION WAS REPORTED TO FDA PER 21 CFR PART 806. THE DEVICE WILL BE CORRECTED PER RES 88058. CORRECTION: DEVICE 510K NUMBER IN G4 WAS INCORRECTLY REPORTED AS K131982. THE CORRECT 510K NUMBER IS K113068.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IN ON-GOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245099 REMSTAR PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 461P 00606959030213

    Patients

    Seq Age Sex Outcome Treatment
    1