BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O_TWO E700

    MDR report key: 8242540 · Received January 11, 2019

    Report

    Report Number
    9610861-2019-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 11, 2019
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES INC.
    Product Code
    BTL
    PMA / PMN Number
    K141595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 WE WERE MADE AWARE THAT A SALES DEMO UNIT (SN (B)(4)) CAUGHT FIRE DURING CUSTOMER EVALUATION. THERE WAS PATIENT INVOLVEMENT BUT IT WAS CONFIRMED BY THE AMBULANCE SERVICE THAT THERE WAS NO PATIENT OR STAFF INJURY. THE CUSTOMER DISCONNECTED THE DEVICE AND REMOVED IT FROM THE VEHICLE. IT WAS MENTIONED THE INCIDENT HAD OCCURRED WHILE THE DEVICE WAS CONNECTED TO THE EXTERNAL POWER SUPPLY. THE SALES REPRESENTATIVE WAS INSTRUCTED TO SHIP THIS UNIT BACK TO US IMMEDIATELY FOR INVESTIGATION TO DETERMINE THE CAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35311 O_TWO E700 AUTOMATIC TRANSPORT VENTILATOR BTL O-TWO MEDICAL TECHNOLOGIES INC. 01EVE700

    Patients

    Seq Age Sex Outcome Treatment
    1