MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID TYPE D PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-33
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6)centre & research.Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during routine check the cardiosave intra-aortic balloon pump (iabp) was not switching on.No patient involved and no harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse confirmed that the device did not power on and emitted beep sound.Found problem with display monitor to video generator board kit which have been replaced.All functional tests were performed and all calibrations were verified.Required calibration of vacuum and pressure regulators was done.Unit was tested with system trainer with balloon pumping and found working in satisfactory condition.

• Brand Name: CARDIOSAVE HYBRID TYPE D 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: 50492021
• Report Number: 2249723-2026-0004021
• Device Sequence Number: 10224237
• Product Code: DSP
• UDI-Device Identifier: 10607567109008
• UDI-Public: (01)10607567109008
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 0998-00-0800-33
• Device Catalogue Number: 0998-00-0800-33
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/28/2026
• 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