BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX

    MDR report key: 17788965 · Received September 21, 2023

    Report

    Report Number
    2518422-2023-24018
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 7, 2023
    Report Date
    May 23, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY CONTACTED IN REFERENCE TO A CUSTOMER COMPLAINT STATING THAT DURING A SERVICE EVALUATION AND DISASSEMBLY PROCESS, AN ISSUE WAS IDENTIFIED WITH THE HUMIDIFIER BASE CABLE BEING BURNT. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE MANUFACTURER RECEIVED NEW AND RELEVANT INFORMATION ON 01/13/2025. THE DEVICE WAS RETURNED FOR LAB INVESTIGATION BY PIL, DURING THE EXTERNAL AND INTERNAL INVESTIGATION IT IS OBSERVED THAT EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THIS DEVICE. PIL INITIATED THERAPY WITH THE DEVICE AND VERIFIED AIRFLOW, USING A KNOWN GOOD PIL SUPPLIED POWER SUPPLY AND AC POWER CORD. HIGH PITCH BLOWER WHINE OBSERVED. 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. PIL ALSO OBSERVED HIGH PITCH BLOWER WHINE, AIR INLET FILTER MISSING, UI (USER INTERFACE) KNOB BROKEN, THE AIR OUTLET PORT HAD WHITE DUST-LIKE CONTAMINATION IN IT, AIR INLET HAD TAN DUST-LIKE CONTAMINATION IN IT, PCA (PRINTED CIRCUIT ASSEMBLY) HAD DUST-LIKE CONTAMINATION ALL OVER THE TOP OF IT. MISSING PCA SCREW FROM SERVICE, THERMAL EVENT ON HUMIDIFIER HARNESS CONNECTOR AND PCA AT J9. DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER BOX LID AND SURROUNDING AREA, DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER MOTOR AND INSIDE OF THE BLOWER BOX, POTENTIAL MINERAL DEPOSITS IN BLOWER BOX INDICATE POSSIBLE WATER INGRESS, BOTTOM ENCLOSURE HAD DUST-LIKE CONTAMINATION IN IT, AIR INLET SEAL HAD YELLOWED AND HAD DUST-LIKE CONTAMINATION ON IT, THE SOUND ABATEMENT FOAM WAS INTACT AND HAD SIGNIFICANT DUST-LIKE CONTAMINATION ON TOP OF IT. THE SOURCE OF CONTAMINATION WAS MOST LIKELY EXTERNAL TO THE DEVICE. PIL WAS ABLE TO GET CARE ORCHESTRATOR INFORMATION FROM DEVICE. PIL WAS ABLE TO CONFIRM THE COMPLAINT OF BURNT HUMIDIFIER BASE CABLE. J9 THERMAL EVENT INV0636. FOUND 0 ERRORS WERE LOGGED. THE RESULTS OF THIS INVESTIGATION DO NOT IMPACT THE CALCULATED RISKS. SECTION G3 HAS BEEN UPDATED. IN ADDITION, APPROPRIATE CODE UPDATED/CORRECTED.

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID AND CONCLUSION CODE GRID HAVE BEEN CORRECTED AND UPDATED IN THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A CUSTOMER COMPLAINT STATING THAT DURING A SERVICE EVALUATION AND DISASSEMBLY PROCESS, AN ISSUE WAS IDENTIFIED WITH THE HUMIDIFIER BASE CABLE BEING BURNT. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND THE 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
    2053424 REMSTAR PRO C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN461S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown