BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21855848 · Received April 17, 2025

    Report

    Report Number
    2249723-2025-0001816
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 31, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, THE BLOOD PRESSURE WAVEFORM IS NOT DISPLAYED PROPERLY AND CALIBRATION IS NOT PERFORMED. VISITED THE HOSPITAL AND CHECKED THE DEVICE. FIBER OPTIC MODULE TEST: PWM 43 LAMP OUTPUT 194 LAMP OUTPUT/PWM 4.51 SIGNAL COUNT 145 SIGNAL LEVEL 156. RUNNING TEST USING OPTICAL SENSOR BALLOON. NO ABNORMALITIES. OPTICAL SENSOR CONNECTOR CLEANING. NO ABNORMALITIES WERE FOUND ON THE DEVICE SIDE DURING THIS OPERATION CHECK. PLEASE KEEP AN EYE ON THE SITUATION FOR A WHILE. IF A SIMILAR PHENOMENON OCCURS, PLEASE CONSIDER ADJUSTING THE BALLOON PLACEMENT POSITION AND PERFORMING MANUAL CALIBRATION.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: D10.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING CLINICAL USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BLOOD PRESSURE WAVEFORM WAS NOT DISPLAYED PROPERLY. NO IMPACT ON PATIENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30652 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 TRANSRAY PLUS 35 CC.| UNKNOWN.