MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE I (AU); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-31
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer that cardiosave intra-aortic balloon pump (iabp) had powercord not retract.During repair of the retractable power cord but found that the cord is damaged.No harm and injury reported.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Correction fields: h6(investigation finding, health effect - impact code).
Event or Problem Description
N/a.
Event or Problem Description
It was reported by customer that cardiosave intra-aortic balloon pump (iabp) had powercord not retract.During repair of the retractable power cord but found that the cord is damaged.No harm and injury reported.No patient involved.
Additional Manufacturer Narrative
Due to character limit in e1: full initial reporter's name: (b)(6).Updated fields: b4, b5, b6, d10, e1, g1, g3, g6, h2, h6, h11.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6- (type of investigation, investigation findings, investigation conclusion, component code) and h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that they were able to repair the retractable power cord but found that the cord is damaged.The customer declined quotation as they don't want to repair.Should repairs be done at a later time the investigation will be reopened.

• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• 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: 22714868
• Report Number: 2249723-2025-0003377
• Device Sequence Number: 9923992
• Product Code: DSP
• UDI-Device Identifier: 10607567109053
• UDI-Public: (01)10607567109053
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 0998-00-0800-31
• Device Catalogue Number: 0998-00-0800-31
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 01/21/2026; 01/23/2026
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/23/2026; 01/23/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown