BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS¿ CPR CHEST COMPRESSION SYSTEM

    MDR report key: 12150067 · Received July 12, 2021

    Report

    Report Number
    0003015876-2021-01394
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 17, 2021
    Report Date
    April 22, 2022
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    DRM
    UDI-DI
    00883873834329
    PMA / PMN Number
    K161768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1, MANUFACTURING SITE, OF INITIAL MFR# 0003015876-2021-01394 INCORRECTLY LISTED JOLIFE AB - 3005445717. THIS HAS BEEN CORRECTED TO PHYSIO-CONTROL, INC. - 3015876. THE CUSTOMER WAS CONTACTED NUMEROUS TIMES FOR MORE DETAILS, BUT NO RESPONSE APPEARS TO BE FORTHCOMING. THE DEVICE HAS NOT BEEN RETURNED TO STRYKER FOR EVALUATION. THE REPORTED ISSUE COULD NOT BE VERIFIED AND THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE FORM OF A HEMOTHORAX. THERE WAS PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. DEVICE NOT EVALUATED BY MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE FORM OF A HEMOTHORAX. THERE WAS PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045783 LUCAS¿ CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL / DRM DRM PHYSIO-CONTROL, INC. - 3015876 LUCAS 00883873834329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other