BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAC VU 360 RESTING ECG ANALYSIS SYSTEM

    MDR report key: 17712371 · Received September 8, 2023

    Report

    Report Number
    3008729547-2023-00008
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 10, 2023
    Report Date
    January 9, 2024
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    DPS
    PMA / PMN Number
    K173830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G1: CONTACT EMAIL CHANGED AND EMAIL UPDATED. INVESTIGATION FINDINGS: THE REPORTED ISSUE WAS CAUSED BY A THERMAL RUNAWAY DUE TO THE SUDDEN INTERNAL SHORT CIRCUIT WITHIN A CELL OF THE TOTEX BATTERY. THIS RESULTED IN THE MAC VU360 EXPLODING. CONSEQUENTLY, A PATIENT WAS STRUCK IN THE RIGHT EYE BY DEBRIS. THE PATIENT WAS TREATED FOR THE INJURES IN THE EMERGENCY ROOM AND EXAMINED BY A CLINICIAN FROM AN EYE CLINIC WHICH IT WAS REPORTED, THE INJURES DID NOT APPEAR TO BE SERIOUS. DETAILS OF THE MEDICAL TREATMENT WERE NOT PROVIDED TO GEHC. THIS INCIDENT IS UNIQUE TO GEHC AS NO OTHER SIMILAR INCIDENTS HAVE BEEN REPORTED. BASED ON THE INVESTIGATION, THERE IS NO EVIDENCE OF DESIGN DEFICIENCY OF THE DEVICE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    BLOCK A1, A2 AND A4 : PATIENT INFORMATION NOT CURRENTLY AVAILABLE. BLOCK D4: UDI (B)(4). GE HEALTHCARE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Description of Event or Problem · 0

    A PATIENT/USER SUSTAINED INJURIES FROM A REPORTED FIRE/EXPLOSION FROM A MAC VU360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510282 MAC VU 360 RESTING ECG ANALYSIS SYSTEM ELECTROCARDIOGRAPH DPS CRITIKON DE MEXICO S. DE R.L. DE C.V. 2030360-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention