MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-53
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
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 patient use, the cs300 intra-aortic balloon pump (iabp) had a wave form issue.The unit was printing only very short (1 second) clips of the waveforms and not dossing to their patient information server.There was no patient harm reported.
Additional Manufacturer Narrative
Updated fields: b4, d4 (model, catalog, udi), d9, g3, g4 ,g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10.(additional contact info: (b)(6)).A getinge field service engineer (fse) was dispatched to evaluate the unit, and during the evaluation, fse confirmed that there was a printing issue upon initial inspection.Fse had found the printer paper to be improperly aligned with the printer.Then, the fse properly "aligned" the printer paper.After that, the unit prints waveforms normally.Even the rs 232 external connection port had been tested and found to function normally.The unit had passed all the tests and calibrations to manufacturer standards and was released for clinical use.
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: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19637679
• Report Number: 2249723-2024-02641
• Device Sequence Number: 7093126
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308(21)SA03871-E5
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 02/18/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/12/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2005
• 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: UNKNOWN.
• Patient Sex: Unknown