BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 22539996 · Received July 18, 2025

    Report

    Report Number
    2249723-2025-0003075
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 19, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS- B4, B5, G3, G6, H2. CORRECTED FIELDS- D10, H11. UDI PROVIDED IN INITIAL EMDR (B)(4) (MFG REPORT NUMBER 2249723-2025-0003075) IS INCOMPLETE AS SERIAL NUMBER OF DEVICE WAS NOT PROVIDED. THIS INFORMATION WAS REQUESTED; HOWEVER, DESPITE OUR BEST EFFORTS, NO INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1, FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G1, G3, G6, H2, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS - G2. (B)(6) RN CALLS TO VERIFY THE TIMING OF THERAPY IS CORRECT FOR HER PATIENT. SHE STATES PATIENT HAD SOME SLIGHT HEMODYNAMIC CHANGES AND THE WAVEFORMS JUST LOOKED DIFFERENT. PATIENT IS POST STENT OF RCA, ON 1:2 THERAPY, AND AWAITING BYPASS SURGERY SCHEDULED FOR THIS SATURDAY. SHE STATES THE OTHER RNS ON HER UNIT WERE NOT SURE HOW TO EVALUATE THE TIMING. TEXTED IMAGES AND DISCUSSION FOLLOWED. TIMING IS APPROPRIATE WITH GOOD HEMODYNAMIC RESULTS. THE PATIENT IS KNOWN TO HAVE MILD AI AND THE DICROTIC NOTCH ON THE AP WAVEFORM IS CONSISTENT WITH THESE FINDINGS. NO ALARMS OR MESSAGES HAVE OCCURRED ON THE CARDIOSAVE ACCORDING TO (B)(6). AP READINGS ARE 89/38, 75MAP, AND 118AUG. (B)(6) IS APPRECIATIVE OF THE SECOND SET OF EYES TO REVIEW THE TIMING AND STATES SHE FEELS MUCH BETTER NOW. COMPLAINT CREATED DUE TO USER ERROR. EST STATED DO NOT THINK THIS PUMP WOULD NEED TO BE SERVICED. THE CALLER WANTED CLINICAL GUIDANCE. NO FURTHER INFORMATION IS AVAILABLE COMPLAINT WILL BE CLOSED AND IN THE EVENT NEW INFORMATION WAS TO BECOME AVAILABLE, THIS RECORD WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED DIFFERENT WAVEFORMS AND PATIENT HAD SOME SLIGHT HEMODYNAMIC CHANGES. THE RN WANTED TO VERIFY THE TIMING OF THERAPY IS CORRECT FOR HER PATIENT. THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840304 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LINEAR 40CC IAB.| UNKNOWN.