BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23671334 · Received November 28, 2025

    Report

    Report Number
    2249723-2025-0004878
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 7, 2025
    Report Date
    March 31, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATIONS: FULL EVENT SITE NAME: (B)(6) MEDICAL CENTER. FULL INITIAL REPORTER NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: E1 (EVENT SITE TELEPHONE), H6 (TYPE OF INVESTIGATION). DUE TO CHARACTER LIMITATION IN BLOCK E1: INITIAL REPORTER: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: A2, A4, B4,G3, G6,H2,H11.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, E3, B5, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES,MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION CONCLUSIONS) A GETINGE FIELD SERVICE ENGINEER FSE WAS DISPATCHED TO THE SITE TO EVALUATE THE UNIT. UPON ARRIVAL, HE STATES THAT BATTERIES SHOWED POOR PERFORMANCE DURING AIR TRANSPORT. BATTERIES EXPIRED IN SEPTEMBER. REPLACED BOTH BATTERY PACKS AND COMPLETED THE PM INCLUDING ALL FUNCTIONAL AND SAFETY TESTS AS PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WOULD NOT STAY POWERED ON DURING A LIFEGUARD TRANSPORT OF PATIENT. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS BATTERY MALFUNCTION ISSUE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. UNIT WOULD NOT STAY POWERED ON DURING A LIFEGUARD TRANSPORT OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311054 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1