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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4; d9; g1; g3; g6; h2; h3; h6 type of investigation, investigation findings, investigation conclusion; h11.Corrected fields: d4 serial number, udi number.A getinge field service engineer (fse) evaluated the unit and found there was a problem with the valve assembly.The hospital contacted a third party for repair and it has been completed.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) failed automatic inflation.Inspection found that there was a problem with the valve assembly.There was no patient harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of investigation.

• 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: 21121743
• Report Number: 2249723-2025-0000141
• Device Sequence Number: 12621548
• 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
• Serviced by Third Party (Y/N): Y
• 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): 04/02/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown