BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IABP (INTRA AORTIC BALLOON PUMP) UNKNOWN

    MDR report key: 22920417 · Received August 29, 2025

    Report

    Report Number
    2249723-2025-0003623
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 29, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # IS INCOMPLETE AS THE CATALOG#, SERIAL # WERE NOT PROVIDED. THIS INFORMATION WAS REQUESTED FROM THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBERS 2249723-2025-0003601 AND 2249723-2025-0003612. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0003601 AND 2249723-2025-0003612 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0003623 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT DURING USE ON PATIENT, WATER KEPT FILLING UP THE TUBING OF IABP (INTRA AORTIC BALLOON PUMP) AND THEN IT WAS REMOVED, BUT IT KEPT COMING BACK. IABP WAS SWITCHED OUT WITH A NEW ONE. THE SAME EXACT ISSUE HAPPENED, BUT IT READ "INTERNAL COMMUNICATION FAIL". THEN IT WAS SHUT OFF AND TURNED BACK ON AND GOT A TON OF ERROR MESSAGES. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130377 IABP (INTRA AORTIC BALLOON PUMP) UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SENSATION PLUS 50CC.