BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXTEC MICROMAX

    MDR report key: 9505546 · Received December 20, 2019

    Report

    Report Number
    2523148-2019-00002
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 26, 2019
    Report Date
    February 5, 2020
    Manufacturer
    PRECISION MEDICAL INC
    Product Code
    BZR
    UDI-DI
    00853061006074
    PMA / PMN Number
    K053232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    02/05/2020 - NOTIFICATION FROM MAXTEC CONFIRMED DEVICE IS NOT BEING RETURNED FROM DISTRIBUTOR "FISHER & PAYKEL HELATHCARE" FOR ADDITIONAL INVESTIGATION. PRECISION MEDICAL INC RECEIVED A INCIDENT - SERVICE REPORT FROM FISHER & PAYKEL HEALTHCARE (FPH COMPLAINT PS:327095) WHICH CONCLUDES THE CAUSE WAS DUE TO A FAULTY PRESSURE GAUGE/REGULATOR CONNECTED ON CYLINDER. REGULATOR WAS NOT MANUFACTURED OR SUPPLIED BY PRECISION MEDICAL INC.

    Description of Event or Problem · 0

    MAXTEC (PRIVATE LABEL DISTRIBUTOR) RECEIVED THE INFORMATION BELOW FROM THEIR CUSTOMER F&P IN INDIA. INFORMATION FORMALLY PROVIDED: ON 26TH NOV, OUR VENDOR WAS IN NICU DEPT FOR INSTALLATION OF BUBBLECPAP WITH MAXTEC BLENDER, AFTER INSTALLATION, VENDOR WAS HAVING FINAL CHECKING OR TRIAL OF PROPER FUNCTIONING OF CPAP DEVICE, WITH A FLOW OF 10 LITER. SUDDENLY THE BLENDER GOT BURST OF FIRE.... THERE WAS NO INJURY TO HOSPITAL STAFF, PATIENTS...OUR CHANNEL PARTNER MET WITH A SUPERFICAIAL BURN OF HIS LEFT HAND AND GOT IMMEDITALEY FIRST AID TREATMENT FROM THE HOSPITAL ADDTIONALLY INFORMATION YET TO BE VERIFIED INDICATES A SLIGHTLY DIFFERENT SEQUENCE OF EVENTS. ALSO, FAILURE (REGULATOR - NOT SUPPLIED BY PRECISION MEDICAL INC) OF ADDITIONAL EQUIPMENT IN THE GAS SUPPLY CIRCUIT. NEITHER CHANGING THE END RESULTS.

    Additional Manufacturer Narrative · 1

    PRECISION MEDICAL INC SHIPPED MICROMAX BLENDER (SN (B)(4)) ON 12/04/2018 TO MAXTEC (PRIVATE LABEL DISTRIBUTOR). 12/17/2019 - MAXTEC NOTIFIED PRECISION MEDICAL INC OF A FIRE INVOLVING A MICROMAX BLENDER (SN (B)(4)) IN (B)(6). MAXTEC INDICATED THE FIRE WAS DUE TO AN ISSUE WITH THE REGULATOR (AN EXTERNAL SOURCE). THE REGULATOR WAS NOT SUPPLIED BY PRECISION MEDICAL INC. 12/19/2019 - PRECISION MEDICAL CONTACTED MAXTEC TO OBTAIN ADDITIONAL INFORMATION TO BE PROVIDED FOR PRECISION MEDICAL INC TO PERFORM AN INTERNAL INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE PRECISION MEDICAL INC RECEIVES ADDITIONAL INFORMATION AND INVOLVED PRODUCTS FROM MAXTEC. AS OF (B)(6) 2019 PRECISION MEDICAL INC HAS RECEIVED A FIRE INCIDENT - SERVICE REPORT INDICATING THE INCIDENT WAS DUE TO A FAULTY REGULATOR NOT SUPPLIED BY PRECISION MEDICAL INC. 12/19/2019 - DOCUMENTATION IN REFERENCE TO THE INCIDENT RECEIVED FROM MAXTEC AND REQUESTED OF MAXTEC IS ATTACHED TO THIS REPORT.

    Description of Event or Problem · 1

    INFORMATION FORMALLY PROVIDED: ON (B)(6), OUR VENDOR WAS IN NICU DEPT FOR INSTALLATION OF BUBBLE CPAP WITH MAXTEC BLENDER, AFTER INSTALLATION, VENDOR WAS HAVING FINAL CHECKING OR TRIAL OF PROPER FUNCTIONING OF CPAP DEVICE, WITH A FLOW OF 10 LITER. SUDDENLY THE BLENDER GOT BURST OF FIRE.... THERE WAS NO INJURY TO HOSPITAL STAFF, PATIENTS...OUR CHANNEL PARTNER MET WITH A SUPERFICIAL BURN OF HIS LEFT HAND AND GOT IMMEDIATELY FIRST AID TREATMENT FROM THE HOSPITAL. ADDITIONALLY INFORMATION YET TO BE VERIFIED INDICATES A SLIGHTLY DIFFERENT SEQUENCE OF EVENTS. ALSO, FAILURE (REGULATOR - NOT SUPPLIED BY PRECISION MEDICAL INC) OF ADDITIONAL EQUIPMENT IN THE GAS SUPPLY CIRCUIT. NEITHER CHANGING THE END RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298350 MAXTEC MICROMAX MICROMAX LOW FLOW BLENDER BZR PRECISION MEDICAL INC PM5300ENMX 12031800031 00853061006074

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention