BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR PLUS

    MDR report key: 20407236 · Received October 9, 2024

    Report

    Report Number
    2518422-2024-61408
    Event Type
    Death
    Date Received
    October 9, 2024
    Date of Event
    October 12, 2023
    Report Date
    May 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005778
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF NOSE IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY AND DEATH. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER INSPECTED EXTERNALLY AND INTERNALLY, OBSERVED INITIATED THERAPY TO THE DEVICE, THERE WAS A SLIGHT WHINY NOISE, POTENTIALLY DUE TO THE DUST LIKE CONTAMINATE ON THE INSIDE OF THE BLOWER. DUST LIKE CONTAMINATE ON THE PHILIPS WHITE ULTRA FINE FILTER, EXTERIOR AND INTERIOR OF THE TOP ENCLOSURE, PCA (PRINTED CIRCUIT ASSEMBLY), FLOW MANIFOLD, EXTERIOR AND INTERIOR OF THE BLOWER HOUSING, BLOWER GROMMET, BLOWER, RIGHT SIDE ASSEMBLY, HUMIDIFIER CABLE, AIR INLET SEAL, EXTERIOR AND INTERIOR OF THE BOTTOM ENCLOSURE, ISO PORT (INTERNATIONAL ORGANIZATION OF STANDARDIZATION), FLIP LID SEAL, DRY BOX, DRY BOX SEAL, DRY BOX INLET SEAL, TOP HOUSING, EXTERIOR AND INTERIOR OF THE HUMIDIFIER BOTTOM ENCLOSURE, HEATER PLATE, HEATER PLATE SPRING, EXTERIOR AND INTERIOR OF THE HUMIDIFIER LOWER BASE, AND THE SOUND ABATEMENT FOAM. MISSING THE UI KNOB (USER INTERFACE), SD CARD, AND THE SD CARD COVER. HAIRLIKE FIBERS ON THE FLIP LID SEAL AND THE HUMIDIFIER LOWER BASE. AN UNKNOWN CONTAMINATE ON THE EXTERIOR OF THE TOP ENCLOSURE WHERE THE UI KNOB WOULD SIT, EXTERIOR OF THE SIDE PANEL, AND THE EXTERIOR OF THE HUMIDIFIER SIDE PANEL. A YELLOWISH TINT ON THE FLOW MANIFOLD, BLOWER GROMMET, BLOWER BELLOW, AIR INLET SEAL, FLIP LID SEAL, DRY BOX SEAL, AND THE DRY BOX INLET SEAL. A PAPER-LIKE SUBSTANCE ON THE INTERIOR OF THE WATER TANK. POTENTIAL BIOCONTAMINATION ON THE BLOWER GROMMET, BLOWER BELLOW, AND THE AIR INLET SEAL. POTENTIAL LIQUID INGRESS WITH A WHITE POWDER CONSISTENT WITH MINERAL DEPOSITS ON THE EXTERIOR AND INTERIOR OF THE HUMIDIFIER FLIP LID, FLIP LID SEAL, WATER TANK, INTERIOR OF THE TOP ENCLOSURE, PCA, BLOWER HOUSING, BOTTOM ENCLOSURE, ISO PORT, DRY BOX SEAL, DRY BOX, AND DRY BOX INLET SEAL. THE SCREW BOSS WAS STRIPPED ON THE RIGHT-SIDE ASSEMBLY. THERMAL DAMAGE TO THE J9 AND ON THE HUMIDIFIER CABLE. THERMAL DAMAGE TO THE J9 HAS BEEN PREVIOUSLY INVESTIGATED AS DOCUMENTED. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION IN THE DEVICE AND THEY WERE UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF NOSE IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY AND DEATH. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. MEDICAL INTERVENTION WAS NOT SPECIFIED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686053 REMSTAR PLUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS260HS 00606959005778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death