BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21591718 · Received March 13, 2025

    Report

    Report Number
    2249723-2025-0001196
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 26, 2025
    Report Date
    July 1, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD : B5 , H6 ( MEDICAL DEVICE ¿ PROBLEM CODE ). UPDATED FIELD : D9 ( RETURN TO MANUFACTURING DATE ). UPDATED FIELDS: B4, D9 ( RETURN TO MANUFACTURING DATE ), G3, G6, H2,H3, H6(INVESTIGATION. FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE HELIUM RESERVOIR ASSEMBLY (0997-00-0565). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 WITH A REPORTED UNIT FAILURE OF AN AUTOFILL ERROR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAVE AUTOFILL ERROR. NO PATIENT HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAVE AUTOFILL ERROR. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917111 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 UNKNOWN.