BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 21856727 · Received April 17, 2025

    Report

    Report Number
    2249723-2025-0001824
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    April 4, 2025
    Report Date
    August 5, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, INITIAL REPORTER FULL NAME: (B)(6). UPDATED FIELDS: B3, B4, B5, B6, B7, D5, D8, D9, D10, E1 (INITIAL REPORTER NAME, MAIL), E2, E3, E4, G2, G3, G6, H2, H6 (HEALTH EFFECT- CLINICAL CODE AND HEALTH EFFECT- IMPACT CODE), H11.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G6, H2, H11. CORRECTED FIELDS: G3.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, (G1(CONTACT OFFICE, CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS) H11. CORRECTED FIELD: B5. A GETINGE FIELD SERVICE ENGINEER (FSE) VERIFIED THE ISSUE AND REPLACED AC LINE CORD AND FIBER OPTIC ASSEMBLY . PRECAUTIONARY SERVICE: REPLENISH ECG LEADS AND OTHER PARTS FOR COMPLETE LIST: ECG LEADS, PRINT PAPER, IV POLE, AND DOPPLER ASSEMBLY. RAN ALL THE TESTS IN ACCORDANCE TO THE MANUFACTURER¿S SPECIFICATIONS. ALL TESTS ARE WITHIN RANGE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART FIBER OPTIC ASSEMBLY AND PART CABLE AC LINE 110V THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND PART CABLE AC LINE 110V OLD AND WORN , WHICH ROOT CAUSE WOULD BE EXPECTED WEAR AND TEAR. PART FIBER OPTIC ASSEMBLY WAS FOUND IN GOOD CONDITION. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF FIBER OPTIC TEST FAIL AND AC POWER LINE CORD OHMS OUT OF TOLERANCE. THE FAT PROCEEDED TO INSTALL PART NUMBER FIBER OPTIC ASSEMBLY INTO THE CS300 TEST FIXTURE SERIAL NUMBER AND TESTED THE FIBER OPTIC ASSEMBLY TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV. W. WHEN THE CS300 BOOTED UP ERROR CODE AP OPTICAL SENSOR MODULE FAILURE WAS OBSERVED ON THE DISPLAY. THE FAT DEPT. THEN BOOTED THE UNIT INTO THE DIAGNOSTIC MODE TO ATTEMPT TO PERFORM THE FIBER OPTIC TEST. THE FAT DEPT. WAS NOT ABLE TO PERFORM THE FIBER OPTIC TEST. THE FAT DEPT. WAS ABLE TO DUPLICATE THE FAILURE. THE FIBER OPTIC ASSEMBLY FAILED TESTING. THE FAT THEN PROCEEDED TO TEST THE LINE CORD VIA THE LEAKAGE TEST AND ALSO DUPLICATED THAT THE OHMS TEST WAS OUT OF TOLERANCE. THE LINE CORD FAILED TESTING. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(4) REV. AU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PM, CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD FIBER OPTIC TEST FAIL AND AC LINE POWER CORD OHMS OUT OF TOLERANCE EST (OLD STYLE CORD). THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD FIBER OPTIC TEST FAIL AND AC LINE POWER CORD OHMS OUT OF TOLERANCE EST (OLD STYLE CORD).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PM, CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD FIBER OPTIC TEST FAIL AND AC LINE POWER CORD OHMS OUT OF TOLERANCE EST (OLD STYLE CORD). THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732971 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.