BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22042172 · Received May 19, 2025

    Report

    Report Number
    2249723-2025-0002250
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    May 5, 2025
    Report Date
    July 31, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT SITE NAME IS: (B)(6). DUE TO CHARACTER LIMIT IN THE E1 SECTION THE EVENT SITE CITY NAME IS: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN THE E1 SECTION THE FULL INITIAL REPORTER NAME IS (B)(6). UPDATED FIELDS: B4, B5, B6, B7, D9, D10, E1- INITIAL REPORTER NAME, E1-EVENT SITE EMAIL, E3, G1- CONTACT PERSON AT MFG SITE, G3, G6, H2, H3, H6-TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUION, COMPONENT CODE AND H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE UNIT DOES NOT TURN ON THE MONITOR. THE FSE REPLACED THE PCBA DISPLAY MONITOR TO VIDEO GEN BOARD (0040-00-0456). THE SCREEN WAS CALIBRATED AND ALL FUNCTIONAL AND SAFETY TEST WERE PERFORMED.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: H6- HEALTH EFFECT IMPACT CODE. UPDATED FIELDS: B4, G3, G6, H2, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CRADIOSAVE INTRA AORTIC BALLOON PUMP HAD A POWER UP FAILURE, WHICH BEEPS CONTINUOSLY AND DEOS NOT TURN ON. THE PATIENT INVOLVEMENT AND INJURY INFORMATION WERE NOT SPECIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION BY CUSTOMER, THE CRADIOSAVE INTRA AORTIC BALLOON PUMP HAD A POWER UP FAILURE, WHICH BEEPS CONTINUOSLY AND DEOSNOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130201 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown