BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVID S70

    MDR report key: 16693828 · Received April 6, 2023

    Report

    Report Number
    9615849-2023-00002
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    February 28, 2023
    Report Date
    May 2, 2023
    Manufacturer
    G.E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    IYN
    PMA / PMN Number
    K170878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: NO PATIENT WAS INVOLVED. BLOCK D4, UDI:(B)(4). LEGAL MANUFACTURER: HCS HAIFA U/S - NATIV HA'OR STREET NO. 1 ISRAEL HAIFA 3508510.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WHILE INITIAL INFORMATION RECEIVED & REPORTED WAS THAT THE GEHC CLINICAL APPLICATIONS SPECIALIST TRIPPED ON A POWER CORD, THE GEHC CLINICAL APPLICATIONS SPECIALIST ACTUALLY TRIPPED ON AN GEHJC ECG TRUNK CABLE, 3/5-LEAD, AHA, 3.6 M/12 FT AND NOT THE POWER CORD. THERE WAS NO MALFUNCTION OF THE ECG CABLE SO THE CABLE WAS NOT EVALUATED. H3 OTHER TEXT : ADDITIONAL INFORMATION WAS RECEIVED STATING THAT WHILE INITIAL INFORMATION RECEIVED & REPORTED WAS THAT THE GEHC CLINICAL APPLICATIONS SPECIALIST TRIPPED ON A POWER CORD, THE GEHC CLINICAL APPLICATIONS SPECIALIST ACTUALLY TRIPPED ON AN GEHJC ECG TRUNK CABLE, 3/5-LEAD, AHA, 3.6 M/12 FT AND NOT THE POWER CORD. THERE WAS NO MALFUNCTION OF THE ECG CABLE SO THE CABLE WAS NOT EVALUATED.

    Description of Event or Problem · 0

    WHILE PERFORMING CUSTOMER TRAINING AT A CUSTOMER SITE A GEHC CLINICAL APPLICATIONS SPECIALIST TRIPPED ON THE VIVID S70 POWER CORD AND FELL, FRACTURING THEIR ELBOW. THERE WAS NO SYSTEM MALFUNCTION. THIS EVENT WAS ALSO RECORDED AS A WORKPLACE SAFETY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853899 VIVID S70 PULSED DOPPLER ULTRASOUND IMAGINGSYS IYN G.E MEDICAL SYSTEMS ISRAEL LTD. NOT SPECIFIED 001828S70

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other