BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MEDICAL - REDMOND_PRODUCT

    MDR report key: 9979787 · Received April 20, 2020

    Report

    Report Number
    0003015876-2020-00532
    Event Type
    Injury
    Date Received
    April 20, 2020
    Date of Event
    March 1, 2020
    Report Date
    April 21, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D2 PRODUCT CODE # OF INITIAL MEDWATCH REPORT INDICATES: MKJ. SECTION D2 PRODUCT CODE # OF THIS MEDWATCH REPORT INDICATES: DRM.

    Description of Event or Problem · 0

    PHYSIO-CONTROL WAS MADE AWARE OF THE ARTICLE "COMPARTMENT SYNDROME OF THE HAND AS A COMPLICATION OF PROLONGED MECHANICAL CARDIOPULMONARY RESUSCITATION" PUBLISHED IN ANAESTHESIA REPORTS 2020-8, THAT MENTIONED A PATIENT EVENT WHERE THE DEVICE USE HAD POTENTIALLY CAUSED COMPARTMENT SYNDROME IN A 45-YEAR-OLD MALE PATIENT DURING MECHANICAL CARDIOPULMONARY RESUSCITATION. CARDIOPULMONARY RESUSCITATION ALONG WITH AGGRESSIVE REWARMING ACHIEVED RETURN OF SPONTANEOUS CIRCULATION. DESPITE PRESERVATION OF NEUROLOGICAL FUNCTION THE PATIENT DIED OF COMPLICATIONS FROM THE CARDIAC ARREST AFTER AN EXTENDED INTENSIVE CARE UNIT STAY.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT USER ERROR CONTRIBUTED TO THE SERIOUS INJURY OF THE PATIENT. THE PATIENT HAD HIS ARM STRAPPED TO THE DEVICE WITH THE PATIENT STRAPS DURING THE PROLONGED RESUSCITATION. THIS RESULTED IN COMPARTMENT SYNDROME TO THE PATIENT'S LEFT HAND. USER ERROR.

    Description of Event or Problem · 1

    PHYSIO-CONTROL WAS MADE AWARE OF THE ARTICLE "COMPARTMENT SYNDROME OF THE HAND AS A COMPLICATION OF PROLONGED MECHANICAL CARDIOPULMONARY RESUSCITATION" PUBLISHED IN ANAESTHESIA REPORTS 2020-8, THAT MENTIONED A PATIENT EVENT WHERE THE DEVICE USE HAD POTENTIALLY CAUSED COMPARTMENT SYNDROME IN A (B)(6)-YEAR-OLD MALE PATIENT DURING MECHANICAL CARDIOPULMONARY RESUSCITATION. CARDIOPULMONARY RESUSCITATION ALONG WITH AGGRESSIVE REWARMING ACHIEVED RETURN OF SPONTANEOUS CIRCULATION. DESPITE PRESERVATION OF NEUROLOGICAL FUNCTION THE PATIENT DIED OF COMPLICATIONS FROM THE CARDIAC ARREST AFTER AN EXTENDED INTENSIVE CARE UNIT STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440460 UNKNOWN_MEDICAL - REDMOND_PRODUCT COMPRESSOR, CARDIAC, EXTERNAL DRM PHYSIO-CONTROL, INC. - 3015876 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other