BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21760084 · Received April 3, 2025

    Report

    Report Number
    2249723-2025-0001577
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 20, 2025
    Report Date
    August 20, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. CORRECTED DATA - E1(EVENT SITE TELEPHONE). A GETINGE FIELD SERVICE ENGINEER (FSE) UPON INSPECTION, CONFIRMED IT WAS LIKELY TO BE CAUSED BY REEL, AC POWER CORD, CEE 7/7 "TYPE E/F" CAUSES NO POWER TO ENTER THE MACHINE. TRIED CHANGING REEL, AC POWER CORD, CEE 7/7 "TYPE E/F" 1 PIECE WITH A NEW ONE AND HAVE THE USER DEPARTMENT TEST THE MACHINE FIRST. FOUND THAT AFTER CHANGING THE POWER CORD STORAGE AND TESTING THE MACHINE, THE POWER ENTERED THE MACHINE NORMALLY. OFFERED A PRICE FOR THE AC POWER CORD SET. THE CUSTOMER HAS NOT YET APPROVED THE REPAIR. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE CHARACTER LIMIT E1: CONTACT PERSON NAME- (B)(6). EVENT SITE NAME- (B)(6). EVENT SITE ADDRESS- (B)(6). SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED TAHT DUEING ROUTINE CHECK CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP), THERE WAS NO POWER TO THE MACHINE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459550 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 N/A.