BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 15032992 · Received July 15, 2022

    Report

    Report Number
    2249723-2022-01741
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 29, 2022
    Report Date
    February 28, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL CONTACT INFORMATION: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BATTERY WON¿T CHARGE -REPLACED BATTERY (0146-00-0039 ) AND CABLE AC LINE CORD (0012-00-0886-01) TO RESOLVE ISSUE. PERFORMED UNIT CHECKOUT. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTES. CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WOULD NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872340 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown