BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8245634 · Received January 14, 2019

    Report

    Report Number
    2248146-2019-00026
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    December 2, 2018
    Report Date
    February 11, 2019
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT # (B)(4); RECORD ID 192914.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT THE INTRA-AORTIC BALLOON PUMP (IABP) SUDDENLY ALARMED "INTERNAL COMMUNICATION FAILURE" AND POWERED OFF BY ITSELF. THE NURSE RESTARTED THE IABP UNIT AND CONTINUED THERAPY WITHOUT INCIDENT. IT WAS SUGGESTED TO THE CUSTOMER TO SWITCH OUT THE IABP UNIT WHEN AND IF CLEARED WITH THE DOCTOR AND TO HAVE THE INITIAL IABP SERVICED. DURING THE EVENT THE PATIENT EXPERIENCED SEVERE CHEST PAIN. THERE WAS NO REPORTED MALFUNCTION OF THE INTRA-AORTIC BALLOON (IAB).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT THE INTRA-AORTIC BALLOON PUMP (IABP) SUDDENLY ALARMED "INTERNAL COMMUNICATION FAILURE" AND POWERED OFF BY ITSELF. THE NURSE RESTARTED THE IABP UNIT AND CONTINUED THERAPY WITHOUT INCIDENT. IT WAS SUGGESTED TO THE CUSTOMER TO SWITCH OUT THE IABP UNIT WHEN AND IF CLEARED WITH THE DOCTOR AND TO HAVE THE INITIAL IABP SERVICED. DURING THE EVENT THE PATIENT EXPERIENCED SEVERE CHEST PAIN. THERE WAS NO REPORTED MALFUNCTION OF THE INTRA-AORTIC BALLOON (IAB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38379 UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening