BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTCB INT CB PKGD

    MDR report key: 1213267 · Received October 27, 2008

    Report

    Report Number
    1022819-2008-00303
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K982317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.

    Description of Event or Problem · 1

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED. THE DEVICE WAS USED ON SIX PTS.

    Description of Event or Problem · 2

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 3

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 4

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 5

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 6

    THE UNIT WAS REPORTED AS HAVING AN UN-INTENDED OUTPUT (SHOCK) DURING THE LAST 10 SECONDS OF THE ELECTROTHERAPY TREATMENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTCB INT CB PKGD IPF, GZJ, GZI IPF CHATTANOOGA GROUP INTCB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention
    2 Required Intervention
    3 Required Intervention
    4 Required Intervention
    5 Required Intervention
    6 Required Intervention