BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 17778516 · Received September 20, 2023

    Report

    Report Number
    2518422-2023-23761
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT: DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    1) 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 DEVICE WAS RECEIVED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY. THE DEVICE HAS BEEN EVALUATED FOR LAB INVESTIGATION. DURING THE EXTERNAL AND INTERNAL EVALUATION OF THE DEVICE,THE ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. THE INVESTIGATION SUMMARY: DEPICTS THAT THERE WAS EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS OBSERVED IN THIS DEVICE. PIL INITIATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A PIL SUPPLIED POWER SUPPLY/AC POWER CORD. BECAUSE OF PATIENT COMPLAINT THE SERVICE EVALUATION SAID THAT ISSUE IDENTIFIED DURING DISASSEMBLY PROCESS WITH BURNT HUMIDIFIER BASE CABLE. PIL USED A KNOWN GOOD PIL SUPPLIED HUMIDIFIER (ETF 3100682-021) ON BASE DEVICE AND VERIFIED THE HEATER PLATE DID HEAT. PIL USED A PIL SUPPLIED KNOWN GOOD HEATED TUBE ON THE KNOWN GOOD PIL SUPPLIED HUMIDIFIER (ETF 3100682-021) AND VERIFIED TUBE DID HEAT. ADDITIONALLY, PIL OBSERVED THE FOLLOWING SOUND ABATEMENT DEGRADED FOAM INDICATIONS: 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. PIL WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE ISSUE OF DEGRADED SOUND ABATEMENT FOAM IS ADDRESSED BY CAPA 7211. THERE WERE SECONDARY FINDINGS AVAILABLE AS: 0 ERRORS WERE LOGGED. SIGNIFICANT DUST-LIKE CONTAMINATION AT THE AIR INLET, ON THE PCA, IN THE BLOWER BOX AND THROUGHOUT THE INSIDE ENCLOSURE. UI (USER INTERFACE) KNOB BROKEN MISSING AIR INLET FILTER THERMAL EVENT ON HUMIDIFIER HARNESS CONNECTOR AND PCA AT J9. (B)(4). POTENTIAL MINERAL DEPOSITS IN BLOWER BOX AND ON THE BOTTOM OF THE BLOWER MOTOR INDICATE POSSIBLE WATER INGRESS. PIL CAN CONFIRM THE PRESENCE OF MULTIPLE CONTAMINANTS THAT ARE NOT CONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM FROM THE SECONDARY FINDINGS. PIL WAS ABLE TO CONFIRM THE COMPLAINT OF BURNT HUMIDIFIER BASE CABLE. J9 THERMAL EVENT (B)(4). 2) THE REPORT WAS SUBMITTED FOR "THERMAL EVENT" WHICH IS NOW UPDATED IN THIS REPORT AND THE DEVICE IS UNDER RECALL, THE FILE IS SUBMITTED AS UNO REPORT. IN ADDITION, "RECALL (Z) NUMBER" IS UPDATED IN THIS REPORT. 3) IN THE PREVIOUS FILE THE REPORT WAS SUBMITTED FOR INITIAL WHICH IS UPDATED TO FINAL IN THIS REPORT. ADDITIONALLY, PROBLEM CODE GRID, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID AND CONCLUSION CODE GRID WERE ALSO UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "BURNT HUMIDIFIER-BASED CABLE" LOCATED ON THE DEVICE DURING THE DISASSEMBLY PROCESS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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
    1615287 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN561S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown