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

Model Number	0998-00-3023-57
Medical Device Problem Codes	Inability to Auto-Fill (1044); Battery Problem (2885); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) unit has a recurring auto-filling failure.Event # 1: during the shift handover, the bcia console assigned to surgery throws the auto-filling failure alarm, despite the same alarm being activated, the balloon does not work, which is why a cardiovascular console must be requested and the incident is reported in the operating rooms event # 2: the console throws an alarm for battery maintenance in the morning, which is reported, around noon it throws an auto-filling failure and despite stopping, zeroing and giving assistance, it does not self-fill, stopping counterpulsation.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.
Additional Manufacturer Narrative
Updated felds: b4, d8, d9, g1- contact person-mfg site g3, g6, h2, h3, h6- type of investigation code, investigation findings, investigation conclusion, and h11.Corrected fields: h6- medical device problem code.After doing 3 good faith effort (gfe¿s) we haven't received any information.As of now, the investigation is closed, if any new information is received future related to part replacement will reopen the complaint and update it.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 19821313
• Report Number: 2249723-2024-02959
• Device Sequence Number: 18320153
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: (01)10607567108254(21)SI206213B5
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

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: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 02/21/2025; 05/02/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 02/21/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2015
• 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: MAQUET SENSATION 7FR. 40CC CATHETER EXTENDER
• Patient Age: 68 YR
• Patient Sex: Female