MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Codes	Communication or Transmission Problem (2896); Appropriate Device Problem Term/Code Not Available (3191); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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 the cardiosave intra aortic ballon pump(iabp) had internal error issue.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11 corrected fields: e1, h6(problem code).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional contact - (b)(6).Updated fields - b4, b5, b6, b7, d10, g3, g6, h2, h6(medical device ¿ problem code, health effect ¿ impact codes, type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that they were unable to recreate the fault.Device passed the performance and safety checks according to factory specifications.
Event or Problem Description
It was reported that the cardiosave intra aortic ballon pump(iabp) had internal error issue while starting up the device.There was no patient involvement.

• Brand Name: CARDIOSAVE HYBRID TYPE J PLUG
• 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: 24791847
• Report Number: 2249723-2026-0002055
• Device Sequence Number: 8938591
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/30/2026

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 04/30/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/23/2026; 04/30/2026
• 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
• Patient Sex: Unknown