BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR AUTO

    MDR report key: 19401484 · Received May 27, 2024

    Report

    Report Number
    2518422-2024-31567
    Event Type
    Death
    Date Received
    May 27, 2024
    Date of Event
    October 9, 2023
    Report Date
    May 2, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005907
    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

    H3 OTHER TEXT : THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    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 AN ISSUE RELATED TO A REMSTAR DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED DEATH. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED EXTERNALLY OBSERVED THAT PIL INITIATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A KNOWN GOOD PRODUCT INVESTIGATION LABORATORY SUPPLIED POWER SUPPLY AND AC POWER CORD. PRODUCT INVESTIGATION LABORATORY ALSO OBSERVED CUSTOMERS TOP ENCLOSURE NOT SEATED CORRECTLY. DC POWER JACK NOT LINED UP WITH HOLE IN TOP ENCLOSURE. UNABLE TO POWER DEVICE IN ITS CURRENT STATE OBSERVED. BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WAS OBSERVED ON THE OUTSIDE BOTTOM OF THE BLOWER BOX AND WAS STUCK TO IT. TINY BLACK PIECES OF A BLACK SUBSTANCE, CONSISTENT WITH SOUND ABATEMENT FOAM DEGRADATION, WERE FOUND ON THE BOTTOM OF THE ENCLOSURE. PRODUCT INVESTIGATION LABORATORY WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE ISSUE OF DEGRADED SOUND ABATEMENT FOAM IS ADDRESSED BY CAPA 7211. THE MANUFACTURER CONCLUDES THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED IN THIS DEVICE. 4 ERRORS WERE LOGGED. SD CARD COVER, UI (USERS INTERFACE) WERE MISSING. TOP ENCLOSURE AND PCA (PRINTED CIRCUIT ASSEMBLY) WERE NOT SEATED CORRECTLY. DUST-LIKE CONTAMINATION AT THE AIR INLET, ON THE PCA, IN THE BLOWER BOX AND THROUGHOUT THE INSIDE ENCLOSURE. PIL COULD CONFIRMED THE PRESENCE OF MULTIPLE CONTAMINANTS THAT ARE NOT CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM FROM THE SECONDARY FINDINGS. IN BOX D: DEVICE AVAILABLE FOR EVAL? AND DATE RETURNED TO MFG HAS BEEN UPDATED. IN BOX H: DEVICE EVAL. BY MFG? (DEVICE) PROBLEM CODE GRID, PATIENT OUTCOME CODE EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID HAS BEEN UPDATED.

    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 THAT PATIENT PASSED AWAY. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    1399960 REMSTAR AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560TS 00606959005907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death