BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 17435726 · Received August 1, 2023

    Report

    Report Number
    2518422-2023-17705
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 21, 2021
    Report Date
    May 14, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005839
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REMSTAR DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED DEVICE HAS STRANGE ODOR DEVICE/POWER CORD OR SUPPLY TOO HOT TO TOUCH. JAW IS SORE AND THE MACHINE IS NOISY. SD CARD WAS RETURNED. NO OTHER PERIPHERALS OR ACCESSORIES WERE RETURNED WITH THE DEVICE. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THIS DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE I (USERS INTERFACE) KNOB BROKEN, SD CARD COVERS MISSING, AIR INLET FILTER MISSING. THE AIR OUTLET PORT HAD DUST-LIKE CONTAMINATION IN IT. AIR INLET HAD WHITE DUST-LIKE CONTAMINATION IN IT. PCA (PRINTED CIRCUIT ASSEMBLY) HAD LIGHT DUST-LIKE CONTAMINATION ALL OVER THE TOP OF IT. DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER BOX LID AND SURROUNDING AREA. DUST-LIKE CONTAMINATION ON THE TOP OF THE BLOWER MOTOR. DUST-LIKE CONTAMINATION INSIDE OF THE BLOWER BOX. 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 DUST-LIKE CONTAMINATION ON TOP OF IT. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THIS DEVICE. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. BECAUSE OF A CUSTOMER COMPLAINT OF DEVICE/POWER CORD OR SUPPLY TOO HOT TO TOUCH, A THERMAL TEST WAS RUN. WHILE USING TEST LUNG,HARD SIDED (1021671) WITH THE REMSTAR PRO C-FLEX+,W/HUMSYSONE60SRS, DOM IN COMBINATION WITH THE CUSTOMER SUPPLIED HUMIDIFIER DS6HFLG (SN (B)(6)) THE TEMPERATURE TEST CONSISTED OF RECORDING THE SURFACE TEMPERATURE OF THE BASE, HUMIDIFIER DS6HFLG (SN (B)(6)), AND PIL SUPPLIED POWER SUPPLY/AC POWER USING AN INFRARED THERMOMETER. TEMPERATURE WAS ALSO RECORDED ON THE CUSTOMER SUPPLIED HUMIDIFIER DS6HFLG (SN (B)(6)) HEATER PLATE USING AN OMEGA THERMOMETER. A THERMOCOUPLE (USING A MULTIMETER (TEMPERATURE FUNCTION)) WAS ATTACHED TO THE PATIENT PORT AIRPATH TUBE. ALL 5 OF THESE TEMPERATURES WERE RECORDED EVERY 15 MINUTES. THESE TESTS WERE PERFORMED WITH WATER IN THE WATER TANK. THE HUMIDIFIER WAS SET TO LEVEL 5. THE PRESSURE SETTING ON THE DEVICE WAS SET TO 20.0CMH20. THE BASE MAX TEMPERATURE RECORDED WAS 29°C AND HUMIDIFIER WAS WITHIN THE PLATFORM (OUTSIDE ENCLOSURE SURFACE) TEMPERATURE SPECIFICATIONS PER PRD 2300068 V43. HUMIDIFIER DS6HFLG (SN (B)(6)) MAX TEMPERATURE RECORDED WAS 28.1°C. THE HEATER PLATE MAX TEMPERATURE WAS RECORDED AT 53.0°C WAS WITHIN THE PLATFORM TEMPERATURE SPECIFICATIONS PER PRD 2300068 V43. THE PATIENT PORT AIRPATH MAXIMUM TEMPERATURE RECORDED WAS 25.2°C AND WAS WITHIN THE TEMPERATURE SPECIFICATIONS (WORST CASE OUTLET AIR TEMP CONDITIONS) PER PRD 2300068 V43. THE POWER SUPPLY/AC POWER MAX TEMPERATURE RECORDED WAS 31.6°C (OUTSIDE ENCLOSURE SURFACE) AND WAS WITHIN THE TEMPERATURE SPECIFICATIONS PER PRD 2300068 V43. DURING A CHANGE TO THE COMPLIANCE LOGGER, THE SEMAPHORE TIMER EXPIRES, AND THE SEMAPHORE IS RELEASED. THIS CAN OCCUR OF THE MODEM IS REMOVED WHILE THE COMPLIANCE LOGGER HAS CONTROL OF THE SEMAPHORE. THE MANUFACTURER ALSO OBSERVED POTENTIAL PAPER TOWELS IN WATER TANK. FLIP LID SEAL HAD UNKNOWN DARK CONTAMINATION ON IT. WHITE AND TAN DUST-LIKE CONTAMINATION, THROUGHOUT HUMIDIFIER ENCLOSURE. UNKNOWN WHITE DUST-LIKE CONTAMINATION ON AND UNDER THE HEATER PLATE. UNKNOWN WHITE DUST-LIKE CONTAMINATION ON THE DRY BOX SEALS AND HAS YELLOWED. UNKNOWN WHITE DUST-LIKE CONTAMINATION ON THE INSIDE OF WATER TANK. UNKNOWN WHITE AND TAN DUST-LIKE CONTAMINATION IN THE ISO PORT (INTERNATIONAL ORGANIZATION OF STANDARDIZATION). THE CONTAMINATION FOUND IN THE HUMIDIFIER ENCLOSURE IS CONSIDERED NOT TO BE IN THE AIRPATH. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. THE MANUFACTURER WAS ABLE TO GET CARE ORCHESTRATOR INFORMATION FROM DEVICE AND UNABLE TO CONFIRM COMPLAINT OF MACHINE IS NOISY WITH A HIGH PITCH BLOWER WHINE BUT NOT ABLE TO VERIFY DEVICE/POWER CORD OR SUPPLY TOO HOT TO TOUCH OR ADDRESS THE SYMPTOMS SPECIFIED. REVIEW OF THE DEVICE LOG SHOWED: ERROR LOGGED: 15 ERRORS WERE LOGGED. BLOWER HOURS: 14,469.4 WERE LOGGED. THERAPY HOURS: 14,445.6 WERE LOGGED. COMPLIANCE RATE (PERCENT OF DAYS WITH USAGE >= 4 HOURS): 97.8%. DEVICE HUMIDIFICATION SETTINGS: HUMIDIFIER PRIMARILY SET TO 1. IN BOX D: DEVICE SERVICED BY 3RD PARTY? DEVICE AVAILABLE FOR EVAL? AND DATE RETURNED TO MFG HAS BEEN UPDATED. IN BOX H: DEVICE EVAL. BY MFG.? (DEVICE) PROBLEM CODE GRID, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 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 RECEIVED INFORMATION ALLEGING DEVICE HAS STRANGE ODOR/POWER CORD OR SUPPLY IS TOO HOT TO TOUCH AND THE MACHINE IS NOISY. PATIENT REPORTS EXPERIENCING A SORE JAW. 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
    2337960 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460HS 00606959005839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown