BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT, MAIN MODULE

    MDR report key: 13673845 · Received March 4, 2022

    Report

    Report Number
    1416980-2022-00894
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 8, 2022
    Report Date
    February 20, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS - (B)(6). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: D1 BRAND NAME, D4 INFORMATION, G1 INFORMATION (UPDATE TO INCLUDE 2 POTENTIAL MANUFACTURERS), G2 (ADD SOURCE), H8, H10. G1 MANUFACTURING FACILITY - THE DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - ENGLEWOOD 14445 GRASSLANDS DR ENGLEWOOD, CO 80112 UNITED STATES. PLEXUS CORPORATION 2500 MILLBROOK DRIVE BUFFALO GROVE, IL 60089 UNITED STATES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A POWER CORD SHEATH IS CUT AND WIRES WERE EXPOSED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979769 REPLACEMENT, MAIN MODULE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown