BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12577422 · Received October 5, 2021

    Report

    Report Number
    2518422-2021-04778
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 27, 2021
    Report Date
    June 30, 2022
    Manufacturer
    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 THAT A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A SERIOUS LUNG COMPLAINT. THE PATIENT DID RECEIVE MEDICAL INTERVENTIONS THAT RESULTED IN A HOSPITALIZATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER QUALITY PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. DURING THE INITIAL VISUAL INVESTIGATION OF THE EXTERIOR OF THE DEVICE, THE MANUFACTURER FOUND NO SIGNS OF DAMAGE, WEAR, TEAR, OR ANYTHING UNUSUAL. THE AIR INLET FILTER WAS NOT PRESENT ON THE RETURN OF THE DEVICE. INTERNAL INSPECTION FOUND MINIMAL DUST CONTAMINATION ON THE PCA AND EXTERIOR OF THE BLOWER BOX ENCLOSURE. DUST CONTAMINATION WAS ALSO OBSERVED ON THE INTERIOR OF THE BLOWER ENCLOSURE AND IMPELLER. THE SOUND ABATEMENT FOAM DID HAVE EVIDENCE OF LIGHT TO MODERATE DUST CONTAMINATION AND RETURNED TO ORIGINAL SHAPE AFTER COMPRESSION. THE DEVICE WAS POWERED ON AND WAS FOUND TO OPERATE PROPERLY. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND NO ERRORS LOGGED. THE MANUFACTURER CONCLUDES THERE IS NO EVIDENCE OF FOAM DEGRADATION WITHIN THE DEVICE AND MINIMAL PRESENCE OF DUST CONTAMINATION IN THE AIRPATH. THE PRESENCE OF DUST ON THE SOUND ABATEMENT FOAM NEAR THE AIR INLET SUGGESTS THE SOURCE OF CONTAMINATION IS EXTERNAL. SECTION D9, G3, H3, H6 WERE UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A SERIOUS LUNG COMPLAINT. THE PATIENT DID RECEIVE MEDICAL INTERVENTIONS THAT RESULTED IN A HOSPITALIZATION. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477729 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DE562S 00606959030503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O