MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-83
Medical Device Problem Codes	Disconnection (1171); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on patient cardiosave intra aortic balloon pump (iabp) had occurred internal communication error and multiple lead disconnections.There was no harm or injury reported to the patient.
Additional Manufacturer Narrative
Updated fields : b4, b5, g3, g6, h2, h6 (health effect ¿ clinical code, type of investigation, investigation findings, component codes , investigation conclusions),h11 a getinge field service engineer (fse) attended the site, inspected the unit, and performed the power management board recall.The engineer confirmed fault code 107 (dsp error) and identified a faulty bp cable for which a replacement was organized.A second engineer replaced the front end board, and the unit subsequently passed all service procedures, calibrations, and est testing.The customer¿s bp cable was not available at the time of repair and was scheduled to be shipped directly from sales.The unit was left in the consultant¿s office, and customer batteries #2 and #3 were placed in the battery charger.
Event or Problem Description
It was reported by the customer that during use the cardiosave intra aortic balloon pump (iabp) displayed an internal communication error along with multiple lead disconnections (la, rl, v) during setup.There was no patient harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h6 (investigation findings, investigation conclusion, component code), h11.A getinge field service engineer (fse) attended the site, inspected the unit, and performed the power management board recall.The engineer confirmed fault code 107 (dsp error) and identified a faulty bp cable (0012-00-1812-01), for which a replacement was organized.A second engineer replaced the front-end board (0670-00-1164), and the unit subsequently passed all service procedures, calibrations, and est testing.The customer¿s bp cable was not available at the time of repair and was scheduled to be shipped directly from sales.The unit was left in the consultant¿s office, and customer batteries #2 and #3 were placed in the battery charger.The following investigation was performed by (b)(4), technician of the maquet failure analysis and testing dept.(fat) wayne, nj: the failure analysis and testing dept.Received part number 0670-00-1164 with a reported unit failure of an internal communication error with multiple code 107.The fat performed a visual inspection and found the part to be in good condition.The fat installed the board in cardiosave test fixture serial number (b)(6) and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.No failure confirmed.Retaining the part in the failure analysis and testing department per procedure number (b)(4).

• Brand Name: CARDIOSAVE RESCUE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23003432
• Report Number: 2249723-2025-0003767
• Device Sequence Number: 21104602
• Product Code: DSP
• UDI-Device Identifier: 10607567108407
• UDI-Public: (01)10607567108407
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-83
• Device Catalogue Number: 0998-00-0800-83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 01/29/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/03/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Male