BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 16067646 · Received December 29, 2022

    Report

    Report Number
    2518422-2022-103462
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 9, 2021
    Report Date
    May 14, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959012530
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, AND H 11 SHOULD BE REPORTED AS THE MANUFACTURER WAS CONTACTED BY VOLUNTARY MEDWATCH (MW 5110920) 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 PATIENT PREVIOUSLY ALLEGES TO HAVE COUGH. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION THE MANUFACTURER' OBSERVED MISSING UI (USERS INTERFACE) CONTROL KNOB. UNKNOWN DUST¿LIKE CONTAMINATION AT THE AIR INLET. RIGHT PANEL ASSEMBLY AND THE AIR OUTLET PORT HAS DUST¿LIKE CONTAMINATION ON THEM. PCA (PRINTED CIRCUIT ASSEMBLY) HAD DUST¿LIKE CONTAMINATION ALL OVER THE TOP OF IT, ESPECIALLY NEAR THE UI KNOB. PCA COPPER EDGE PINS HAVE UNKNOWN CORROSION ON THEM. ONE OF THE ANTI-SLIP BOTTOM MOUNTS WAS MISSING. DUST¿LIKE CONTAMINATION ON THE TOP OF THE BLOWER MOTOR AND INSIDE OF THE BOTTOM ENCLOSURE AND ON TOP OF SOME OF THE SOUND ABATEMENT FOAM, THAT IS VISIBLE. BLOWER BOX HAD TINY DUST¿LIKE FIBERS AND CONTAMINATION ON THE INSIDE OF END PANEL HAD DUST¿LIKE CONTAMINATION ON THE INSIDE OF IT. THE BOTTOM OF THE ENCLOSURE HAD DUST¿LIKE CONTAMINATION ALL INSIDE OF INLET SEAL HAD YELLOWED AND THERE WAS WHITE DUST¿LIKE CONTAMINATION ON IT. THE SOUND ABATEMENT FOAM WAS INTACT AND HAD SLIGHT DUST¿LIKE CONTAMINATION ON TOP OF IT. DS6TFLG (HUMIDIFIER) WATER TANK LID HAD UNKNOWN SPECKS OF CONTAMINATION AND STAINS OF CONTAMINATION ON TOP OF IT. WATER TANK HAS SPECKS OF POTENTIAL MINERAL DEPOSITS OR DEBRIS IN IT AND ON THE WATER PAN. WATER TANK INSIDE LID HAD POTENTIAL FLUID/ WATER SPOTS ON IT. OUTLET PORT OF THE SIDE PANEL HAS DUST¿LIKE CONTAMINATION ON IT. SIGNIFICANT UNKNOWN DUST¿LIKE CONTAMINATION ON THE BOTTOM OF THE ENCLOSURE AND ON THE HEATER PLATE. FLIP LID SEAL HAD POTENTIAL BIO CONTAMINATION ON IT. THE MANUFACTURER CAN CONFIRM THE PRESENCE OF MULTIPLE CONTAMINANTS THAT ARE NOT CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM. THE MANUFACTURER WAS ABLE TO GET CARE ORCHESTRATOR INFORMATION FROM DEVICE AND WAS NOT ABLE TO CONFIRM THE COMPLAINT OR ADDRESS THE MANUFACTURER OBSERVED 32 ERRORS WERE LOGGED, FOR THE PURPOSE OF THIS INVESTIGATION, CONSIDERED IRRELEVANT. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. IN BOX G: DATE RECEIVED BY MFG HAS BEEN UPDATED. IN BOX H: (DEVICE) PROBLEM CODE GRID, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED BY VOLUNTARY MEDWATCH (MW 5110920) 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 PATIENT ALLEGES TO HAVE COUGH. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. 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
    2238938 BIPAP AUTOSV ADV VENTILATOR, NON-CONTINUOUS (RESPIRATOR) MNS RESPIRONICS, INC. DS960TS 00606959012530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown