MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-65
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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 that during use on a patient, the cs100 intra-aortic balloon pump (iabp) there was no arterial waveform on display.Operated with ecg trigger and transported to mie university hospital.Transferred to cardiosave at mie university hospital.The cardiosave displayed arterial pressure waveform and functioned normally.There was no health hazard.
Additional Manufacturer Narrative
Updated field: b4, d9, g3, g6, h2, h4, h6(type of investigation, investigation findings, investigation conclusions),h10.It was reported that during use the cs100 intra-aortic balloon pump (iabp) had a issue of no arterial pressure waveform was displayed.A getinge field service engineer tested but no reproducibility.Fse have already explained to the hospital that it is not reproducible.There was patient involvement.No health damage reported.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).

• Brand Name: CS100 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19115245
• Report Number: 2249723-2024-01556
• Device Sequence Number: 7099660
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684(21)SA134585G8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 01/29/2025
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/07/2024; 01/29/2025
• Date Device Manufactured: 07/15/2008
• 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: TRANSRAY CATHETER.
• Patient Sex: Unknown