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

Model Number	0998-00-0800-52
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b1, b4,d10, g3, g6, g7,h2, h6(type of investigation, investigation findings, investigation conclusions), h11 corrected field: e2, g2 kindly revert a1(patient id) and h4 as it should be kept blank.Due to characters limiti in e1 event site address is (b)(6) a getinge field service engineer (fse) evaluated the device and provided loaner batteries to replace the existing batteries.The removed batteries were returned to the service office for the cardiosave battery calibration process.One calibrated battery set was returned and installed in the device.Following installation, the unit was tested and operated as intended.The device successfully passed all performance verification tests in accordance with factory specifications.The device was returned to the customer and cleared for clinical use.
Additional Manufacturer Narrative
Event site name: (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 end user that during routine check, the cardiosave intra-aortic balloon pump (iabp) displays battery maintenance due message.There was no patient involvement.No harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that batteries calibration process was performed.Product passed all functional and safety tests per manufacturer specifications.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 50784835
• Report Number: 2249723-2026-0004304
• Device Sequence Number: 18523018
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/16/2026

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: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown