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

Model Number	0998-00-3023-58
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the cs300 intra-aortic balloon pump (iabp) had a broken cart handle.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
It was reported that the device the cs300 intra-aortic balloon pump (iabp) broken cart handle.A getinge field service engineer (fse) evaluated the unit and confirmed the issue.Fse confirmed due to the lack of stock on the part of the factory to supply the original material, the handle broken in the area where it is fastened with screws, is replaced by one from a trolley from a unit removed for technological renovation from another hospital.
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).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, investigation conclusions), h10.Additional fields: e1(event site state: 33, event site postal code: (b)(6).It was reported that the device the cs300 intra-aortic balloon pump (iabp) broken cart handle despite gfes (good faith efforts), the repair has not been carried out at the moment.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.There was no patient involvement.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 19152280
• Report Number: 2249723-2024-01607
• Device Sequence Number: 8501206
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• UDI-Public: (01)10607567108339(21)SI179328G0
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup,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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/30/2024; 01/29/2025
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/17/2024; 08/30/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose