BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATASCOPE INTRA-AORTIC PUMP

    MDR report key: 3812320 · Received May 6, 2014

    Report

    Report Number
    2249723-2014-00660
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP CALLED THE CUSTOMER TO OBTAIN ADD'L INFO. THE BIOMEDICAL PERSON HAD NO KNOWLEDGE OF THE EVENT. CUSTOMER DID NOT GENERATE ANY SERVICE TO THE IABP. ADD'L INFO IS BEING REQUESTED TO THE CUSTOMER. TWO OTHER COMPLAINTS WERE OPENED TO DOCUMENT THE REPORTED FAILURES (B)(4). THE ADVERSE EVENT WILL BE DOCUMENTED ON THIS COMPLAINT (2249723-2014-000660) BECAUSE THE PATIENT DEATH OCCURRED ON THIS DEVICE. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING, "(B)(6) AMBULANCE TEAM SWITCHED PATIENT FROM (B)(6)MEMORIAL HOSPITAL'S CS300 IN PREPARATION FOR TRANSPORT. THEY WERE UNABLE TO ESTABLISH AN ECG TRACE. PATIENT HAD A TRANSVENOUS PACEMAKER. MEDSTAR AMBULANCE TEAM WAS CALLED TO TAKE OVER THE TRANSPORT. MEDSTAR SWITCHED PATIENT TO THEIR CARDIOSAVE AND WAS UNABLE TO ESTABLISH ECG. PATIENT WAS PUT BACK ON (B)(6) CS300. DURING TRANSPORT PATIENT ARRESTED AND PASSED AWAY. AMBULANCE RETURNED TO (B)(6). RISK MANAGEMENT AT (B)(6) HAS REPORTED TO THE AUTHORITIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271821 DATASCOPE INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death