BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16146287 · Received January 12, 2023

    Report

    Report Number
    2249723-2023-00195
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 30, 2022
    Report Date
    March 14, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    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

    UPDATED FIELDS: B4,D9,E1(SITE COUNTRY),G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10. IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) TOUCH PANEL FREEZE. GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT ORDERED LCD TOUCH DISPLAY.1-5-23 REPLACED LCD TOUCHSCREEN DISPLAY (D160-00-0123). A FULL CALIBRATION AND FUNCTIONAL CHECK HAS BEEN PERFORMED PER THE FACTORY CALIBRATION PROCEDURES. RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. BIOMED CONTROL # 72-10805. THE PATIENT INVOLVEMENT IS UNKNOWN. THE EQUIPMENT WAS CLEARED FOR CUSTOMER USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPT. WAS NOT ABLE TO CALIBRATE THE TOUCHSCREEN. THE TOUCHSCREEN FAILED TESTING. RETAINING THE TOUCHSCREEN IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AK. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS TOUCH PANEL IS FROZEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392497 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown