BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER

    MDR report key: 12414644 · Received September 2, 2021

    Report

    Report Number
    2518422-2021-03667
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    August 30, 2021
    Report Date
    May 4, 2022
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959030220
    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 AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. 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 DEVICE WAS DISASSEMBLED FOR INTERNAL VISUAL INSPECTION. THE MANUFACTURER FOUND EVIDENCE OF DUST CONTAMINATION INSIDE THE DEVICE. MODERATE DUST CONTAMINATION WAS OBSERVED IN THE BLOWER AND ON THE IMPELLER. THE SOUND ABATEMENT FOAM WAS FOUND NO EVIDENCE OF DEGRADATION AND RETURNED TO ITS ORIGINAL SHAPE AFTER BEING COMPRESSED. SOUND ABATEMENT FOAM DID HAVE EVIDENCE OF HEAVIER DUST CONTAMINATION THAN THE REST OF THE DEVICE. MICROSCOPIC REVIEW OF THE CONTAMINANTS SHOWED A SEMI-TRANSPARENT YELLOW SOLID CONTAMINANT AND WHITE COLORED CONTAMINATE. MANY FIBER CONTAMINANTS WERE OBSERVED AS WELL. 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 PRESENCE OF DUST THROUGHOUT THE ENTIRE AIRPATH, ESPECIALLY AT THE AIR INLET BEHIND WHERE THE FILTER WOULD SIT, SUGGESTS THE SOURCE OF CONTAMINATION IS FROM AN EXTERNAL SOURCE. CORRECTION TO THE SECTION E1.

    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 LUNG CANCER. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. 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
    1309487 REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC DE462S 00606959030220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other