BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 9538407 · Received January 2, 2020

    Report

    Report Number
    2248146-2020-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    January 23, 2020
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K112327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: D1 - 'BRAND NAME' CHANGED TO SENSATION PLUS 8FR. 50CC IAB. D4 - 'CATALOG #' CHANGED TO 0684-00-0575. 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. COMPLAINT RECORD # : (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED, THE HOSPITAL TOOK IN A TRANSPORT WITH A GETINGE NON-FIBER OPTIC BALLOON AND WHEN CONNECTED TO THE ARROW IABP(INTRA-AORTIC BALLOON PUMP) THE CONNECTOR KEPT ALARMING THE ARROW PUMP. THEY STATED THAT THE CONNECTOR DID NOT SEEM TO FIT VERY WELL. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, THE HOSPITAL TOOK IN A TRANSPORT WITH A GETINGE NON-FIBER OPTIC BALLOON AND WHEN CONNECTED TO THE ARROW IABP(INTRA-AORTIC BALLOON PUMP) THE CONNECTOR KEPT ALARMING THE ARROW PUMP. THEY STATED THAT THE CONNECTOR DID NOT SEEM TO FIT VERY WELL. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1