MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-55
Medical Device Problem Codes	Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 event site address: (b)(6).Another contact info: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by fse during routine checks that the cs100 is not getting switched off.Unit tested and seems power supply is defective.There was no patient involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1, g2, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) inspected the unit and identified a defective power supply as the likely cause.The customer provided a replacement power supply, which was installed by the fse.Following replacement, the unit was tested for more than four hours and functioned normally.The device was subsequently handed over to the customer in good working condition.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
• 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: 24805702
• Report Number: 2249723-2026-0002083
• Device Sequence Number: 18808271
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: (01)10607567107295
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K031636
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/20/2026
• 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.
• Patient Sex: Unknown