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 Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a routine check the cardiosave intra-aortic balloon pump (iabp) was unable to turn on.No patient was involved and no harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that when attempting to turn on the equipment, the screen remains black.At times, the screen turns white, but then returns to black, with a constant alarm sounding.Errors presented indicate a possible failure in the executive processor board, requiring replacement of the board.The device also had no batteries.Equipment not released for use, awaiting replacement of executive processor board and batteries.Prior to this event, the equipment had been out of service for over a year, remaining switched off and stored in the warehouse.The current clinical engineering team is new and therefore has no history or information about what previously occurred.
Additional Manufacturer Narrative
E1 - event site name: (b)(6).E1 - event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50943770
• Report Number: 2249723-2026-0004509
• Device Sequence Number: 9534184
• Product Code: DSP
• UDI-Device Identifier: 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,User Facility,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown