BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMA ACTIVATOR II DRIVE MECHANISM

    MDR report key: 1501622 · Received September 14, 2009

    Report

    Report Number
    3006262933-2009-01021
    Event Type
    Malfunction
    Date Received
    September 14, 2009
    Report Date
    August 25, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETAILS: MAQUET RECEIVED THE PRODUCT ON 09/10/2008. THE VISUAL INSPECTION SHOWED THAT THERE WERE SCRATCHES AND DISCOLORATION ON THE DRIVE. THE PRODUCT IS UNDER INVESTIGATION BY MAQUET QE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING MULTIPLE CORONARY ARTERY BYPASS PROCEDURES OVER THE LAST FEW WEEKS, FOUR BRAND NEW UA-5001 DRIVES JAMMED AFTER OPENING THE PT'S CHEST. THE STAFF HAD A HARD TIME REMOVING THE DEVICES FROM THE CHEST WITH THEIR HANDS. REPLACEMENT DEVICES WERE USED TO COMPLETE THE PROCEDURES. NO PT COMPLICATIONS WERE REPORTED BY THE HOSP. SINCE IT IS UNK WHEN THE CASES OCCURRED OR HOW MANY FAILED IN EACH CASE, ALL FOUR DRIVES WILL BE TRACKED IN THIS ONE CASE. THIS REPORT IS FOR THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA ACTIVATOR II DRIVE MECHANISM NONE DWS MAQUET CARDIOVASCULAR UA-5001 080122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA