BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP AVAPS30

    MDR report key: 14337639 · Received May 9, 2022

    Report

    Report Number
    2518422-2022-19104
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 23, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959045651
    PMA / PMN Number
    K102465
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-19104-1 WITH INCORRECT SECTIONS B1, B2, H1, H6. CORRECTIONS TO PREVIOUS MDR ARE MADE IN THIS REPORT AS FOLLOWS. SECTION B1 WAS CORRECTED TO ADVERSE EVENT AND PRODUCT PROBLEM. (ONLY PRODUCT PROBLEM WAS CHECKED IN PREVIOUS MDR). SECTION B2 WAS CORRECTED TO OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. (PREVIOUSLY IT WAS BLANK). SECTION H1 WAS CHANGED FROM MALFUNCTION TO SERIOUS INJURY. SECTION H6- HEALTH IMPACT CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM.   ADDITIONAL INFORMATION WAS RECEIVED AND SECTION B5 SHOULD BE REPORTED AS:   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 BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED TO HAVE BLADDER CANCER. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE REPORTED EVENT OF BLADDER CANCER AND ITS REPORTED SEVERITY WAS REVIEWED BY THE MANUFACTURE'S CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON THE AVAILABLE INFORMATION, THE MANUFACTURE CONCLUDES NO FURTHER ACTION IS NECESSARY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT.   THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HAS SWAPPED OUT THE DEICE AT THE DISTRIBUTOR AND AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.   SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED BLADDER CANCER. THE PATIENT HAS ALLEGED TO SEEING A WHITE POWDER IN THE TANK AND HUMIDIFIER. THE PATIENT DID REPORT TO RECEIVE MEDICAL INTERVENTION AND IS TAKING A PRESCRIBED MEDICATION, BCG. 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
    1804774 DREAMSTATION BIPAP AVAPS30 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX1130H11C 00606959045651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R