BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21855970 · Received April 17, 2025

    Report

    Report Number
    2249723-2025-0001783
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    April 3, 2025
    Report Date
    October 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT: E1: EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, G1, G3, G6, H2, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: E1(INITIAL REPORTER, EVENT SITE EMAIL), E2, E3, E4, H6(MEDICAL DEVICE ¿ PROBLEM CODE). THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE UPON INSPECTION BOTH LITHIUM BATTERIES LED¿S WERE FLASHING WHILE CONNECTED TO AC POWER, BOTH LITHIUM BATTERIES WERE NOT CHARGING VIA SERVICE MENU; REGARDLESS OF EITHER POWER SLOT. BOTH POWER SLOTS SHOWED THE MWH CAPACITY DROPPING IN EACH BATTERY. NO SIGNS OF CONTAMINATION OR SALINE ABUSE THROUGHOUT THE UNIT. REPLACED POWER MANAGEMENT BOARD (0670-00-1162) AND CONFIRMED THE UNITS BATTERIES MWH CAPACITY WAS STILL DROPPING. PROCEEDED TO REPLACE THE UNITS CART POWER SUPPLY (0014-00-0258) AND REPLACED THE MAIN AC POWER CORD (0012-00-1688-21) OUT OF PER CAUTION. CONNECTED THE UNIT TO AC POWER FOR 1 HOUR. CONFIRMED THE MWH WAS STEADILY INCREASING AND BOTH BATTERIES WERE ABLE TO CHARGE. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS RETURNED TO CUSTOMER.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: H6 (MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION FINDINGS), B5. UPDATED FIELD: B4, G3, G6, H2, H11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORITC BALLOON PUMP (IABP), BATTERY WAS NOT CHANGING. THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), BATTERIES WON¿T CHARGE ON AC POWER AND INSERTED IN THE CART AND FIBER OPTICS CABLE WAS BROKEN. THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORITC BALLOON PUMP (IABP), BATTERY WAS NOT CHANGING. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787510 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 NA Unknown