MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-65
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300, ecg waveform not input externally.When an electrocardiogram signal was input into the external input unit in preparation for starting treatment, the waveform was not input.Healthcare professional trying to change cables and did not improve the situation, so they switched to another machine and started treatment.The switch itself only took a few minutes, and as it was during preparation for starting treatment, there was no delay in treatment.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
E1: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300, ecg waveform not input externally.When an electrocardiogram signal was input into the external input unit in preparation for starting treatment, the waveform was not input.Healthcare professional trying to change cables and did not improve the situation, so they switched to another machine and started treatment.The switch itself only took a few minutes, and as it was during preparation for starting treatment, there was no delay in treatment.No harm or injury to the patient was reported.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2,h3, h6(investigation findings, type of investigation, investigation conclusions), h11 , e1 ( event site email ) corrected field : b3 , b5 , b6 , b7 , d10 , h6 ( health effect ¿ impact codes ) a getinge field service engineer (fse) subsequently inspected the affected unit but was unable to reproduce the reported issue.Based on the hospital¿s verification and assessment, the issue may be attributable to a faulty external input section or a malfunctioning internal circuit board.The cs300 is an end-of-service product and is no longer eligible for repair.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 24547348
• Report Number: 2249723-2026-0001600
• Device Sequence Number: 9386191
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)10607567108322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• 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
• 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: Health Professional
• Device Model Number: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/09/2026
• 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
• Patient Sex: Unknown