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

Model Number	0998-00-3013-58
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a broken cable.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a broken ecg cables.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6 (health effect ¿ clinical code), h10.Additional info: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Getinge field service engineer (fse) or cancelled, managed through supply quote the reference of the broken cable is (b)(4), it has been ordered as a supply of material since it is said cable, so the customer will not be contacted and the work order will be closed because it is not necessary to open it.H3 other text : repair is not done by getinge.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.

• Brand Name: CS100 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: 19042614
• Report Number: 2249723-2024-01392
• Device Sequence Number: 12568520
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: (01)10607567107622(21)SA02557-D4
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2025

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: Other
• Device Model Number: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 06/24/2024; 01/26/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/18/2024; 06/25/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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