BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON ACUNAV¿ ULTRASOUND CATHETER

    MDR report key: 6396032 · Received March 10, 2017

    Report

    Report Number
    3009498591-2016-00253
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    July 24, 2015
    Report Date
    October 11, 2021
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K071234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL SUBMISSION NARRATIVE: THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION; HOWEVER, IT WAS EVALUATED BY THE SIEMENS FIELD SERVICE ENGINEER ON-SITE AND HAD VERIFIED THAT THE DEVICE FAILED TO FUNCTION AS IT WAS SUPPOSED TO. THE REPORTED EVENT OF DEVICE FAILING TO INITIALIZE WAS CONFIRMED. NOTE: THE ORIGINAL EMDR WAS SUBMITTED TO THE NON-PRODUCTION ENVIRONMENT. THIS REPORT IS TO SUBMIT TO THE PRODUCTION ENVIRONMENT.

    Description of Event or Problem · 0

    SIEMENS MEDICAL SOLUTIONS USA, INC. RECEIVED A MEDSUN MANDATORY AND VOLUNTARY REPORT # (B)(4) WHICH STATES: "INTRACARDIAC ECHO (ICE) ULTRASOUND CATHETER FAILED TO INITIALIZE DURING AN EMERGENT PERICARDIOCENTESIS IN THE CONTEXT OF LEFT VENTRICULAR PERFORATION SECONDARY TO PVC ABLATION. DEVICE WAS SAVED AND TESTED BY SIEMENS FIELD SERVICE ENGINEER. THE ENGINEER VERIFIED THAT THE CATHETER FAILED TO INITIALIZE." MULTIPLE ATTEMPTS MADE TO THE USER FACILITY VIA EMAIL TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179933 ACUSON ACUNAV¿ ULTRASOUND CATHETER ULTRASOUND CATHETER OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. UNK N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male