BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER

    MDR report key: 12203708 · Received July 21, 2021

    Report

    Report Number
    2518422-2021-02398
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 20, 2022
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030503
    PMA / PMN Number
    K113068
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REPORTED A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM ALLEGEDLY BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP ACUTE KIDNEY FAILURE. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS RECEIVED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED. THE EXTERNAL INVESTIGATION FOUND NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE MANUFACTURER VERIFED THAT POWER CORDS AND POWER SUPPLIES WERE FUNCTIONAL BY POWERING ON THE BASE UNIT AND INITIATING THERAPY. THE DEVICE'S ERROR LOG WAS REVIEWED AND THE MANUFACTURER CONFIRMED NO ERRORS WERE LOGGED. AN INTERNAL INVESTIGATION WAS PERFORMED ON THE DEVICE. THE MANUFACTURER CONFIRMED THE DEVICE HAD NO EVIDENCE OF FOAM DEGRADATION. THE MANUFACTURER FOUND EVIDENCE OF MODERATE DUST AND DIRT ON THE SOUND ABATEMENT FOAM, IN THE BLOWER BOX, ON THE BLOWER AND ON THE BLOWER IMPELLER. THE MANUFACTURER FOUND DISCOLORATION TO THE BLOWER WIRE SEAL AND THE AIR INTAKE SEAL CONSISTENT WITH TOBACCO CONTAMINATION.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP ACUTE KIDNEY FAILURE. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS RECEIVED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. 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
    1098426 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS, INC. DE562S 00606959030503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R