BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12270644 · Received August 3, 2021

    Report

    Report Number
    2518422-2021-02649
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 4, 2022
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    UDI-DI
    00606959030503
    PMA / PMN Number
    K091319
    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 PREVIOUSLY REPORTED THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM ALLEGEDLY BECAME DEGRADED AND REQUIRED THE PATIENT TO HAVE A CARCINOMA REMOVAL. THE DETAILS OF THE PATIENT'S REQUIRED MEDICAL INTERVENTION ARE UNKNOWN. 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 EVIDENCE OF LIGHT PHYSICAL DAMAGE AND MINOR CONTAMINATION AROUND THE DISPLAY. THE MANUFACTURER ALSO FOUND EVIDENCE OF MINOR CORROSION TO THE POST UI.THE AIR INLET FILTER WAS NOT PRESENT ON THE RETURN OF THE DEVICE. THE SILICONE AT THE AIR INLET HAD A BROWN DISCOLORATION. INTERNAL INSPECTION FOUND DUST CONTAMINATION THROUGHOUT THE DEVICE. THE MANUFACTURER FOUND DUST CONTAMINATION AND A SMOKY ODOR TO THE BLOWER AND ON THE IMPELLER CONSISTENT WITH TOBACCO CONTAMINATION. MOST OF THE SILICONE SURFACES HAD A BROWN DISCOLORATION. THE SOUND ABATEMENT FOAM HAD NO EVIDENCE OF DEGRADATION AND RETURNED TO ORIGINAL SHAPE WHEN COMPRESSED. SOUND ABATEMENT FOAM DID HAVE HEAVIER DUST CONTAMINATION THAN THE REST OF THE DEVICE. MANY FIBER CONTAMINANTS WERE OBSERVED AND WAS FOUND TO HAVE A DARK DISCOLORATION OBSERVED IN THE BLOWER IMPELLER AND SOUND ABATEMENT FOAM, CONTAMINANTS WERE OBSERVED AS WELL. THE DEVICE WAS POWERED ON AND WAS FOUND TO OPERATE PROPERLY. THE MANUFACTURER CONCLUDES THERE IS NO EVIDENCE OF FOAM DEGRADATION WITHIN THE DEVICE. THE PRESENCE OF DUST THROUGHOUT THE ENTIRE AIRPATH, ESPECIALLY AT THE AIR INLET BEHIND WHERE THE FILTER WOULD SIT, IS FROM AN EXTERNAL SOURCE.

    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 REQUIRED THE PATIENT TO HAVE A CARCINOMA REMOVAL. THE DETAILS OF THE PATIENT'S REQUIRED MEDICAL INTERVENTION ARE UNKNOWN. 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
    1163353 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 Other