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

Model Number	0998-00-0800-75
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in the e1 section event site name , the full event site name is (b)(6).Due to character limit in the e1 section event site address, the full event site address is (b)(6).A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the cardiosave intra aortic balloon pump had a intermittent ecg signal during use.The ecg signal was sometimes available and sometimes not.The electrode position was adjusted and the connection was checked.The fault still existed.The electrode was attached to the head nurse for on-site testing.The electrode fault was indeed reported after a while.The signal was restored by slightly moving the lead wire clip.There was no patient injury.
Additional Manufacturer Narrative
Due to character limit in the e1 section event site telephone number, (b)(6).Updated fields: b4, g3, g6, h2, h3, h6- (type of investigation code, investigation findings code, investigation conclusion code, componenet code), h11.A getinge field service engineer (fse) stated that the electrode was attached to the head nurse for on-site testing.The fault could be reproduced.The lead wire clip was not clamped tightly.After replacing the lead wire (d012-00-1814-02), the test was normal.The device passed all factory-specified performance and safety index tests.The device has been delivered to the customer and can be used clinically.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE RESCUE, CHINESE
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21444366
• Report Number: 2249723-2025-0000842
• Device Sequence Number: 20622603
• Product Code: DSP
• UDI-Device Identifier: 10607567112312
• UDI-Public: (01)10607567112312
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 0998-00-0800-75
• Device Catalogue Number: 0998-00-0800-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/20/2025
• 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
• Patient Sex: Unknown