BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 12371879 · Received August 26, 2021

    Report

    Report Number
    2518422-2021-03382
    Event Type
    Death
    Date Received
    August 26, 2021
    Date of Event
    August 18, 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 DEATH. THE REPORTER ALLEGED HEADACHE AND DIZZINESS. 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 SILICONE AT THE AIR INLET HAD VISIBLE DUST CONTAMINATION. MINOR PHYSICAL DAMAGE WAS OBSERVED ON THE RIGHT SIDE (HUMIDIFIER SIDE). DUST CONTAMINATION WAS ALSO VISIBLE ON THE POWER SUPPLY AND CABLE. INTERNAL INSPECTION FOUND DUST CONTAMINATION THROUGHOUT THE DEVICE INTERNALS. MODERATE DUST CONTAMINATION WAS OBSERVED IN THE BLOWER AND ON THE IMPELLER. THE BLOWER BOX, BLOWER AND BLOWER ENCLOSURE HAD EVIDENCE OF WATER INGRESS. THE SOUND ABATEMENT FOAM DID NOT APPEAR TO HAVE 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 AS WELL. THE MANUFACTURER APPLIED POWER TO THE DEVICE AND 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, SUGGESTS THE SOURCE OF CONTAMINATION IS LIKELY EXTERNAL.

    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 DEATH. 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
    1270360 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 Death