BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 3900969 · Received June 30, 2014

    Report

    Report Number
    3003793491-2014-00306
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE FOLLOWING RELATED MFR REPORT: 3003793491-2014-00307 FOR PATIENT # 2. ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THERE WERE TWO INCIDENTS WHERE THE PATIENT WAS POTENTIALLY NOT COOLED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE THAT THE DATE OF EVENT IS UNKNOWN AND THIS REPORT IS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379934 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0658-40 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1