BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 22165399 · Received June 9, 2025

    Report

    Report Number
    2249723-2025-0002520
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Report Date
    August 25, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDS BELIEVED IT WAS BECAUSE OF THE POWER MANAGEMENT BOARD. CUSTOMER ASKED TO SEND A SO REPORT FOR REPAIR. NO OTHER INFORMATION AVAILABLE, IN FUTURE IF WE RECEIVE ANY INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION. UPDATED FIELDS: B4; B5; 7A; D9; G3; G6; H2; H3; H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11. CORRECTED FIELDS: E1 EVENT SITE TELEPHONE; G1 CONTACT PERSON ¿ MFG SITE; H5; H6 HEALTH EFFECT. IMPACT CODES (1), HEALTH EFFECT. CLINICAL CODE (1).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4; G3; G6; H11. AFTER FURTHER INVESTIGATION, IT WAS IDENTIFIED THAT THIS COMPLAINT EVENT HAS BEEN REPORTED ALREADY UNDER MFG REPORT NUMBER 2249723-2025-0002251. PLEASE REFER TO MFG REPORT NUMBER 2249723-2025-0002251 FOR ALL INFORMATION FOR THIS COMPLAINT EVENT. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0002520 IN YOUR DATABASE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN ON A PATIENT. PATIENT INVOLVED AND NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRA AORTIC BALLOON PUMP(IABP) UNKNOWN HAS A SHUT DOWN WHILE USING ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632943 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.