BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLING MONITOR

    MDR report key: 13212170 · Received January 10, 2022

    Report

    Report Number
    1416980-2022-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 15, 2021
    Report Date
    February 27, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE DEVICE CASE WAS DAMAGED IN TRANSIT BACK TO THE CUSTOMER FROM A PREVIOUS REPAIR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CONFIRMATION WAS RECEIVED THAT THE REPORTED CONDITION WAS A BROKEN CASE. THERE WAS NO LIVE ELECTRICAL AND OR/MOVING MECHANICAL PARTS EXPOSURE REPORTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM ENCLOSURE OF A STARLING MONITOR WAS DAMAGED. DURING AN UNSPECIFIED PROCESS STEP, IT WAS OBSERVED THAT THE HOUSING WAS CRACKED EXPOSING LIVE ELECTRICAL AND/OR MOVING MECHANICAL PARTS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984216 STARLING MONITOR SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown