BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12283371 · Received August 5, 2021

    Report

    Report Number
    2518422-2021-02651
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 23, 2021
    Report Date
    January 20, 2025
    Manufacturer
    RESPORINOC 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 CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM ALLEGEDLY BECAME DEGRADED. THE PATIENT HAS INDICATED MEDICAL INTERVENTION WAS REQUIRED IN THE FORM OF PRESCRIBED STEROIDS, PATIENT WAS DEVELOPED SINUS AND EYE INFLAMMATION. PATIENT ALSO ALLEGED HYPERTENSION AND SUGAR FOR YEARS. 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 NO EVIDENCE OF PHYSICAL DAMAGE OR CONTAMINATION WERE FOUND. THE AIR INLET FILTER WAS NOT PRESENT. THE DEVICE WAS DISASSEMBLED FOR INTERNAL VISUAL INSPECTION. THE MANUFACTURER FOUND EVIDENCE OF DUST CONTAMINATION INSIDE THE DEVICE. THE BLOWER BOX WIRE GROMMET WAS UNSEATED. THE ONLY DUST OBSERVED IN THE BLOWER BOX WAS INTERIOR TO THE BLOWER IMPELLER AND ON THE BASE OF 2 BLOWER SUPPORT POSTS. THE SOUND ABATEMENT FOAM WAS FOUND NO EVIDENCE OF DEGRADATION AND RETURNED TO ITS ORIGINAL SHAPE AFTER BEING COMPRESSED. THE SOUND ABATEMENT FOAM DID HAVE EVIDENCE OF DUST CONTAMINATION. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND FOUND THE DEVICE TO OPERATE WITHOUT ISSUE OR ERROR CODES. THE MANUFACTURER CONCLUDES THERE IS NO EVIDENCE OF FOAM DEGRADATION WITHIN THE DEVICE. THE DEVICE OPERATED AS DESIGNED. CORRECTION TO THE SECTION H6 TO REFLECT THE ALLEGATION OF THE HYPERTENSION AND SUGAR.

    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

    ADDITIONAL INFORMATION WAS RECEIVED ON NOV 08, 2024 AND SECTION H10 SHOULD BE REPORTED AS: THE MANUFACTURER PREVIOUSLY REPORTED THAT A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM ALLEGEDLY BECAME DEGRADED. THE PATIENT HAS INDICATED MEDICAL INTERVENTION WAS REQUIRED IN THE FORM OF PRESCRIBED STEROIDS, PATIENT WAS DEVELOPED SINUS AND EYE INFLAMMATION. PATIENT ALSO ALLEGED HYPERTENSION AND SUGAR FOR YEARS. SECTION B1 WAS CORRECTED FOR PRODUCT PROBLEM. (BOTH ADVERSE EVENT AND PRODUCT PROBLEM WAS CHECKED IN THE PREVIOUS MDR.) SECTION B2 WAS CORRECTED TO BLANK. (PREVIOUSLY, IT WAS OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS.) SECTION H1 WAS CHANGED FROM SERIOUS INJURY TO MALFUNCTION SECTION H6 WAS CORRECTED AND UPDATED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND THE PATIENT WAS DEVELOPED SINUS AND EYE INFLAMMATION. THE PATIENT DID REQUIRE MEDICAL INTERVENTION IN THE FORM OF PRESCRIBED STEROIDS. 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
    1181632 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS, GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPORINOC INC DE562S 00606959030503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other