BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIWAZE

    MDR report key: 21356620 · Received February 11, 2025

    Report

    Report Number
    3016774528-2025-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 11, 2025
    Report Date
    March 14, 2025
    Manufacturer
    ABMRC LLC
    Product Code
    NHJ
    UDI-DI
    B965BK1810
    PMA / PMN Number
    K231728
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIWAZE CLEAR DEVICE WAS RETURNED TO ABMRC ON JANUARY 21, 2025, FOR EVALUATION. A THOROUGH VISUAL INSPECTION REVEALED NO EXTERNAL DAMAGE OR ISSUES WITH THE POWER RECEPTACLE, AND THE BATTERY WAS IN GOOD CONDITION. UPON POWERING ON THE DEVICE, THE REPORTED ISSUE WAS SUCCESSFULLY REPRODUCED. WHILE NO VISIBLE DAMAGE WAS IDENTIFIED ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), FURTHER ANALYSIS OF THE MAIN CONTROLLER PCBA (MCB) SUGGESTED A POTENTIAL SOLDER PAD DISCONNECTION. THIS MAY HAVE CONTRIBUTED TO DAMAGE TO THE MOTOR. THIS APPEARS TO BE AN ISOLATED INCIDENT AND DOES NOT REQUIRE FURTHER ACTION.

    Additional Manufacturer Narrative · 0

    THE BIWAZE CLEAR DEVICE WAS RETURNED TO ABMRC ON JANUARY 21, 2025, FOR EVALUATION. A THOROUGH VISUAL INSPECTION REVEALED NO EXTERNAL DAMAGE OR ISSUES WITH THE POWER RECEPTACLE, AND THE BATTERY WAS IN GOOD CONDITION. UPON POWERING ON THE DEVICE, THE REPORTED ISSUE WAS SUCCESSFULLY REPRODUCED. WHILE NO VISIBLE DAMAGE WAS IDENTIFIED ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), FURTHER ANALYSIS OF THE MAIN CONTROLLER PCBA (MCB) SUGGESTED A POTENTIAL SOLDER PAD DISCONNECTION. THIS MAY HAVE CONTRIBUTED TO DAMAGE TO THE MOTOR. THIS APPEARS TO BE AN ISOLATED INCIDENT AND DOES NOT REQUIRE FURTHER ACTION.

    Description of Event or Problem · 0

    (B)(6) HOSPITAL CONTACTED US ON JANUARY 13, 2025, TO REPORT AN INCIDENT INVOLVING THE BIWAZE CLEAR DEVICE, SERIAL NUMBER: (B)(6). THE DEVICE WAS CONNECTED TO A PATIENT VIA A BREATHING CIRCUIT ON (B)(6) 2025. DURING USE, THE RESPIRATORY THERAPIST NOTICED SMOKE COMING FROM THE SIDE PANEL OF THE DEVICE'S CONTROL UNIT, WHERE THE COOLING FANS AND HEAT VENTS ARE LOCATED, AND HEARD SCRAPING AND CLUNKING SOUNDS COMING FROM THE CONTROL UNIT. IT WAS IMMEDIATELY REMOVED FROM USE AND SENT TO THE HOSPITAL'S BIOMED DEPARTMENT. THERE WAS NO HARM TO THE PATIENT OR USER, AND NO MEDICAL INTERVENTION WAS REQUIRED. ADDITIONALLY, THE DEVICE DISPLAYED A STEPPER MOTOR ERROR AND IT IS DESIGNED TO AUTOMATICALLY STOP THE THERAPY.

    Description of Event or Problem · 0

    (B)(6) HOSPITAL CONTACTED US ON JANUARY 13, 2025, TO REPORT AN INCIDENT INVOLVING THE BIWAZE CLEAR DEVICE, SERIAL NUMBER (B)(6). THE DEVICE WAS CONNECTED TO A PATIENT VIA A BREATHING CIRCUIT ON (B)(6) 2025. DURING USE, THE RESPIRATORY THERAPIST NOTICED SMOKE COMING FROM THE SIDE PANEL OF THE DEVICE'S CONTROL UNIT, WHERE THE COOLING FANS AND HEAT VENTS ARE LOCATED, AND HEARD SCRAPING AND CLUNKING SOUNDS COMING FROM THE CONTROL UNIT. IT WAS IMMEDIATELY REMOVED FROM USE AND SENT TO THE HOSPITAL'S BIOMED DEPARTMENT. THERE WAS NO HARM TO THE PATIENT OR USER, AND NO MEDICAL INTERVENTION WAS REQUIRED. ADDITIONALLY, THE DEVICE DISPLAYED A STEPPER MOTOR ERROR AND IT IS DESIGNED TO AUTOMATICALLY STOP THE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784046 BIWAZE BIWAZE CLEAR SYSTEM NHJ ABMRC LLC BK181 B965BK1810

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female