BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,DOM

    MDR report key: 13807365 · Received March 18, 2022

    Report

    Report Number
    2518422-2022-08297
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    November 30, 2020
    Report Date
    July 4, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030497
    PMA / PMN Number
    K 131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-08297-1 WAS INCORRECTLY CREATED. PLEASE DISREGARD THE PREVIOUS MDR.

    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 VISUALIZATION OF PARTICLES RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. DURING DEVICE EVALUATION, FOAM DEGRADATION WAS OBSERVED IN THE DEVICE BLOWER RESULTING IN BLOWER BOX REPLACEMENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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
    7305 REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS,DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 560P 00606959030497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown