BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 14597205 · Received June 3, 2022

    Report

    Report Number
    2518422-2022-29263
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 15, 2024
    Manufacturer
    RESPORINOC INC
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED POWER SUPPLY, POWER CORD TOO HOT TO TOUCH, HUMIDIFIER NOT WORKING, MACHINE DOESN'T TURN ON, HEADACHES, NAUSEA. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER USING A KNOWN GOOD POWER SUPPLY AND POWER CORD AND CONFIRMED THAT THE DEVICE POWERS ON AND PROVIDES THERAPY. A HEAT TEST WAS PERFORMED ON THE DEVICE, HEATER PLATE, AND PATIENT PORT TO VERIFY THAT THE TEMPERATURES WERE WITHIN THE REQUIRED PERIMETERS REQUIRED PER 1120833 (V07)-HEATER PLATE, 2226065 (V31)-POWER SUPPLY, AC POWER CORD, AND DC POWER CORD. MANUFACTURER TECH PERFORMED THIS TEST USING AN ASL-5000, A FLUKE THERMOMETER , A FLUKE MULTIMETER. THE TEST RESULTS SHOWED THAT THE HEATER PLATE DID NOT SHOW TEMPERATURES WITHIN THE THRESHOLD REQUIRED, POWER SUPPLY AND THE POWER CORD SHOWED TEMPERATURES WITHIN THE THRESHOLD REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION OBSERVED THE MATERIAL INSIDE THE DISPLAY WAS DAMAGED, AND UI PANEL IS SCRATCHED. THE KEYPAD ON THE TOP ENCLOSURE IS DAMAGED, THE SERIAL LABEL ON THE BOTTOM ENCLOSURE IS DAMAGED. A DUST/DIRT-LIKE CONTAMINATION IS FOUND THROUGHOUT THE DEVICE, FRONT PANEL, TOP ENCLOSURE, REAR PANEL, BOTTOM ENCLOSURE. THE FILTER NEEDED TO BE REPLACED. FUME-BASED/DUST-LIKE CONTAMINATION IS FOUND ON THE ON THE INSIDE OF THE TOP ENCLOSURE, REAR PANEL AND BOTTOM ENCLOSURE. AN UNKNOWN BROWNISH DUST-LIKE MATERIAL IS FOUND AT THE BASE OF THE BOTTOM ENCLOSURE. A DRIED ACCUMULATION OF CONTAMINATION, MOST LIKELY MINERAL DEPOSITS, IS FOUND ON THE BLOWER CAP, BLOWER, BLOWER BOX. A HEAVY LAYER OF DUST-LIKE CONTAMINATION IS FOUND ON THE BLOWER. A CONSIDERABLE AMOUNT OF BLACK CONTAMINATION, MOST LIKELY KERATIN, IS FOUND AT THE BLOWER BOX OUTLET. OBSERVED THAT THE HEATER PLATE HAS DRIED LIQUID SPOTS ON THE BOTTOM, AND THE SCREWS AT THE BASE OF THE UNIT HAVE HEAVY MINERAL DEPOSITS. THESE FINDINGS INDICATE POSSIBLE WATER INGRESS TO THE HEATER PLATE WHICH IS MOST LIKELY CAUSING IT TO FAIL. THE MANUFACTURER USED A FOAM INTEGRITY TEST TOOL AND THE ASSOCIATED PROCEDURE AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND 31 ERRORS. THE MANUFACTURER CONCLUDES UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS. MANUFACTURER OBSERVE DUST/DIRT CONTAMINATION IN THE AIRPATH, LIKELY FROM A SOURCE EXTERNAL TO THE DEVICE AND CONFIRM THAT HUMIDIFIER SEEMS NOT TO BE WORKING, PIL CANNOT CONFIRM THE COMPLAINT ABOUT THE POWER SUPPLY/CORD AS THEY WERE NOT RETURNED WITH THE DEVICE. MANUFACTURER OBSERVED NO EVIDENCE OF DEGRADED SOUND ABATEMENT FOAM. IN THIS REPORT, SECTIONS D9, G3, H3, AND H6 HAVE BEEN UPDATED OR CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED HUMIDIFIER IS NOT WORKING AND MACHINE DOES NOT TURN ON. PATIENT ALSO ALLEGED HEADACHES AND NAUSEA. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. 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
    1801690 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPORINOC INC DSX900T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown