BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPULSE NXT QUICK CASE

    MDR report key: 21803047 · Received April 9, 2025

    Report

    Report Number
    3010617000-2025-00236
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    March 9, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION IS PENDING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED.

    Additional Manufacturer Narrative · 0

    NO PHYSICAL DAMAGE WAS OBSERVED UPON RECEIPT OF THE NXT QUICK CASE (LOT# 240402). BASED ON THE REPORTED DETAILS, THE CREW MEMBER'S SHOULDER INJURY DOES NOT APPEAR TO MEET THE CRITERIA FOR A SERIOUS ADVERSE EVENT. THE EVENT OF A SHOULDER INJURY IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. THE SHOULDER INJURY MAY ALSO BE ATTRIBUTABLE TO THE PHYSICAL STRAIN ASSOCIATED WITH CARRYING A HEAVY PATIENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERGONOMIC DEFICIENCIES IN THE AUTOPULSE NXT QUICK CASE (SERIAL/LOT# (B)(6)), WHICH CONTRIBUTED TO A CREW MEMBER SUSTAINING A SHOULDER INJURY WHILE THE PATIENT (285 LB) WAS CARRIED BY SIX PEOPLE ON THE CASE TARP WHEN THE NXT PLATFORM PERFORMED COMPRESSIONS. ADDITIONAL INFORMATION ABOUT THE SHOULDER INJURY (TYPE, SIDE, SEVERITY, AND TREATMENT) WAS NOT RECALLED OR KNOWN BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421293 AUTOPULSE NXT QUICK CASE CARDIAC RESUSCITATOR, LINE-POWERED DRM ZOLL CIRCULATION, INC. MODEL 200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown