BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 15165192 · Received August 4, 2022

    Report

    Report Number
    2518422-2022-60746
    Event Type
    Death
    Date Received
    August 4, 2022
    Date of Event
    November 23, 2021
    Report Date
    August 1, 2023
    Manufacturer
    RESPIRONICS,INC
    Product Code
    BZD
    UDI-DI
    00606959005891
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 PREVIOUSLY RECEIVED INFORMATION ALLEGING HEART ISSUES, SPENT TIME IN EMERGENCY ROOM BECAUSE OF BREATHING PROBLEMS WHILE USING THIS DEVICE. THERE WAS NO MEDICAL INTERVENTION SPECIFIED. ADDITIONAL INFORMATION WAS RECEIVED AND B5 SHOULD BE: 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 PREVIOUSLY RECEIVED INFORMATION THE PATIENT INITIALLY CONTACTED THE MANUFACTURER ON 11/23/2021 TO REPORT HEART ISSUES, SPENT TIME IN EMERGENCY ROOM BECAUSE OF BREATHING PROBLEMS. THE PATIENT'S WIFE REPORTED A PATIENT HAD PASSED AWAY ON (B)(6) 2022. THE PATIENT'S WIFE REPORTED THAT THE CAUSE OF DEATH WAS KIDNEY FAILURE DUE TO HIS HEART PROBLEMS. THE PATIENT ALSO HAD PNEUMONIA. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. THE REPORTED EVENT AND ITS SEVERITY WERE REVIEWED BY THE MANUFACTURER'S CLINICAL EXPERT. BASED ON AVAILABLE INFORMATION THE EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. UPON REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION, THE PATIENT'S WIFE REQUESTED THAT THE RECORD BE CLOSED BECAUSE HER HUSBAND DIED ON (B)(6) 2022. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED. SECTION H6 HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. PATIENT ALLEGED OF HAVING HEART ISSUES, SPENT TIME IN EMERGENCY ROOM BECAUSE OF BREATHING PROBLEMS WHILE USING THIS DEVICE. 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
    1722014 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O