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

Model Number	0998-00-0446-64
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
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 start up, the cs300 intra-aortic balloon pump (iabp) unit had a screen problem.There was no patient involvement.
Additional Manufacturer Narrative
Updated data: b4, e1(name),(impact).Corrected data: e1 ( email).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Suspect device originally distributed as a sys98xt, upgraded to cs300 using conversion kit.No udi is provided as product was discontinued prior to gudid implementation timeline.
Additional Manufacturer Narrative
Corrected field: d1, d4 (# udi), g4 (510 k), h6 (medical device ¿ problem code).Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (investigation findings, type of investigation, investigation conclusions, component code), h11.A getinge field service engineer (fse) states, screen problem not observed, done disassembly of the screen casings.Disassembly of the screen cable present.Installation of the new cable (d012-00-1059).Reassembly of cover ok.Functional test ok.Electrical test ok.Everything works correctly.

• Brand Name: CS100 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: 18034432
• Report Number: 2249723-2023-04644
• Device Sequence Number: 8185299
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: (01)10607567107509(21)S82089B9
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 0998-00-0446-64
• Device Catalogue Number: 0998-00-0446-64
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 09/29/2024; 07/01/2025
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/05/2023; 09/30/2024; 07/01/2025
• 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