BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY GO VAC

    MDR report key: 15095456 · Received July 25, 2022

    Report

    Report Number
    2523148-2022-00001
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 27, 2022
    Report Date
    July 25, 2022
    Manufacturer
    LONG BEACH MEMORIAL MEDICAL CENTER
    Product Code
    BTA
    UDI-DI
    00855887006580
    PMA / PMN Number
    K971749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/27/2022 PRECISION MEDICAL INC WAS NOTIFIED THAT THERE WAS AN APPARENT FIRE WITH AN INCUBATOR SET-UP WHICH INCLUDED THE PM65 ASPIRATOR. THE DEVICE WAS MANUFACTURED OVER 10 YEARS AGO WHICH IS PAST THE EXPECTED LIFETIME FOR THE DEVICE. PRECISION MEDICAL INC RECEIVED THE PM65 ASPIRATOR BACK FOR EVALUATION WHICH CONTAINED APPARENT SMOG/SOOT AROUND THE EXTERNAL CHARGING CONNECTOR. CHARGER/POWER SUPPLY WAS NOT RETURNED FOR INVESTIGATION. IT IS UNKNOWN IF THE DEVICE HAS EVER BEEN SERVICED; HOWEVER THE BATTERY WAS REPLACED BY THE CUSTOMER AS IT WAS NOT A PRECISION MEDICAL SUPPLIED BATTERY. REVIEW OF MAUDE DATABASE FOR PRODUCT CODE (BTA) FROM 2011 TO PRESENT INDICATES NO TRENDING OF FIRES. INTERNAL COMPLAINT DATA WHICH INDICATES NO ISSUES RELATED TO FIRE FOR THE PM65 SINCE THE RELEASE OF THE DEVICE ON 04/01/1998. APPROXIMATELY (B)(4) DEVICES SHIPPED WITH NO COMPLAINTS RELATED TO FIRES. ORIGIN OF THE FIRE IS MOST LIKELY THE EXTERNAL CHARGING CONNECTOR AS IT HAS THE DARKEST MOST CONCERTED CHARR ON THE DEVICE; HOWEVER, THE POWER SUPPLY AND PHOTOS OF THE POWER SOURCE WERE NOT PROVIDED; THEREFORE NO DECISIVE CONCLUSION OF SOURCE CAN BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER STATED WHEN STAFF CAME IN THE MORNING THEY SAW SOOT FROM AN APPARENT SMALL FIRE COVERING MOST OF THE EQUIPMENT ON THE INCUBATOR. THERE WAS NO FIRE WHEN THEY CAME IN THAT MORNING JUST THE BLACK SOOT. THE INCIDENT STATED HAPPENED OVERNIGHT WHEN NO ONE WAS AROUND. PRECISION MEDICAL INC PM65 ASPIRATOR WAS PART OF THE EQUIPMENT ON THE INCUBATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719950 EASY GO VAC EASY GO VAC ASPIRATOR BTA LONG BEACH MEMORIAL MEDICAL CENTER PM65 041112 00855887006580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown