MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID W/ E/F PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-55
Medical Device Problem Codes	Failure to Power Up (1476); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that prior to use, the cardiosave intra-aortic balloon pump (iabp) displayed error code 6 upon startup.There was no patient involvement reported.No harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse replaced the defective touchscreen assembly and calibrated the unit.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Event site name:(b)(4).Event site telephone: (b)(4).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 50836187
• Report Number: 2249723-2026-0004375
• Device Sequence Number: 21398091
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: Other
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown