BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PATIENT CARE DUAL CONTROL VALVE

    MDR report key: 318603 · Received February 28, 2001

    Report

    Report Number
    9681444-2001-00001
    Event Type
    Injury
    Date Received
    February 28, 2001
    Date of Event
    December 14, 2000
    Report Date
    February 23, 2001
    Manufacturer
    DELFI MEDICAL INNOVATIONS INC.
    Product Code
    KCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2000 PT WAS HAVING A CARPAL TUNNEL RELEASE UNDER BIER BLOCK WHEN PT STARTED TO COMPLAIN OF ARM/CHEST PAIN AND DIZZINESS AND RINGING IN THE EAR. THE ZIMMER PT CARE (ZPC) DUAL CONTROL VALVE (ZIMMER PART NUMBER 60-750-401) AND BIER BLOCK CUFF WERE REMOVED AND A SINGLE PORT CUFF WAS APPLIED TO TRY AND MAINTAIN THE BLOCK. THE VALVE WAS RETURNED BY THE HOSP TO THE ZIMMER DISTRIBUTOR WHICH THEN FORWARDED THE VALVE AND A ZIMMER PRODUCT EXPERIENCE REPORT (PER) ON THE EVENT TO ZPC IN OHIO IN 12/2000. A PACKAGE CONTAINING THE VALVE AND A LETTER FROM ZPC QA DEPT WAS HAND DELIVERED TO DELFI MEDICAL INNOVATIONS (MFR) IN 01/2001. THE LETTER DID NOT CONTAIN A COPY OF THE ZPC PRODUCT EXPERIENCE REPORT, WHICH WAS REQUESTED IN A LETTER FAXED TO ZPC QA DEPT IN 01/2001. THE ORIGINAL LETTER AND PER ARRIVED AT DELFI BY REGULAR MAIL IN 01/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8201 ZIMMER PATIENT CARE DUAL CONTROL VALVE DUAL CONTROL VALVE FOR ZIMMER ATS 750 TOURNIQUET CONTROLLER KCY DELFI MEDICAL INNOVATIONS INC. 60-0750-401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention 12/14/2000| ZIMMER ATS 750 TOURNIQUET CONTROLLER,