BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLVE HALO VEST SHORT LAMSWOOL

    MDR report key: 5513714 · Received March 21, 2016

    Report

    Report Number
    1836248-2016-00002
    Event Type
    Death
    Date Received
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    KQZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VEST CURRENTLY PROVIDES INSTRUCTIONS FOR EMERGENCY ACCESS TO THE CHEST AS SHOWN IN THE PHOTO ATTACHED. FURTHER DETAILS WILL BE GATHERED FROM THE HOSPITAL AND WE WILL PROVIDE A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    THE VEST CURRENTLY PROVIDES INSTRUCTIONS FOR EMERGENCY ACCESS TO THE CHEST AS SHOWN IN THE PHOTO ATTACHED. WE HAVE INITIATED A PREVENTATIVE ACTION TO MAXIMIZE THE VISIBILITY OF THE EMERGENCY LABEL AND/OR CHANGE THE LABELS TO SYMBOLS RATHER THAN TEXT. -

    Description of Event or Problem · 1

    PATIENT WAS WEARING HALO VEST AND REQUIRED EMERGENCY CPR. THE STAFF DID NOT KNOW THE CORRECT PROCEDURE TO REMOVE THE VEST TO ADMINISTER CPR. THE PATIENT DIED.

    Description of Event or Problem · 1

    PATIENT WAS WEARING HALO VEST AND REQUIRED EMERGENCY CPR. THE STAFF DID NOT KNOW THE CORRECT PROCEDURE TO REMOVE THE VEST TO ADMINISTER CPR. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169693 RESOLVE HALO VEST SHORT LAMSWOOL COMPONENT, TRACTION, NON-INVASIVE KQZ OSSUR AMERICAS, INC. 545700L

    Patients

    Seq Age Sex Outcome Treatment
    1 Death