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	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b1, b4, d10, g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions), h11\ \ corrected field: g2\ \ due to character limitation in block e1: event site name: (b)(6) hospital\ \ kindly revert a1(patient id) and h4 as it should be kept blank.\ \ a getinge field service engineer (fse) evaluated the device and determined that the reel, ac power cord was defective.The power cord was found to have internal damage, resulting in an intermittent open circuit that could not be visually identified.The fse replaced the defective power cord reel assembly.Following the repair, all functional and safety checks were performed in accordance with factory specifications and the device passed all testing.The unit was returned to service.\ no fault logs were available for review.The defective component was discarded by the customer and was not returned for evaluation.
Additional Manufacturer Narrative
Event site postal code: 211012.\ \ 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 mains supply.There was no patient involved, no harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that power cord gone defective and needs to be replaced.After replacing the ac power cord, the problem was solved.All functional and safety checks have been performed to factory specifications, and the unit has been returned to use.
Event or Problem Description
N/a.

• 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: 50866829
• Report Number: 2249723-2026-0004406
• Device Sequence Number: 21511797
• Product Code: DSP
• UDI-Device Identifier: 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown