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	Output Problem (3005); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 full event site name: (b)(6).Full event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported during maintenance that a cardiosave intra-aortic balloon pump (iabp) may need maintenance.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was showing "iabp may need maintenance" message.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4; d9; g3; g6; h2; h3; h6 type of investigation, investigation findings, investigation conclusion: h11.Corrected fields: e3 g1 contact person ¿ mfg site; h6 problem code.The customer identified the issue, but no further information available because the equipment haven't been inspected yet.Since this equipment isn't covered by any maintenance contract, service will only be provided after the customer approves the quote sent with the cost of the service.The proposal was sent to the customer, but they didn't approve it.Due to the length of time without communication from the customer, it was decided to close this issue.No further information is available complaint will be closed and, in the event, new information was to become available, this record will be reopened and updated.

• 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: 22131959
• Report Number: 2249723-2025-0002450
• Device Sequence Number: 8526437
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/29/2025

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 07/29/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/28/2025; 07/29/2025
• 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