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

Model Number	0998-00-3013-68
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
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, the cs100 intra-aortic balloon pump (iabp) had a black screen.
Event or Problem Description
It was reported that before use, the cs100 intra-aortic balloon pump (iabp) had a black screen.When starting the equipment, the screen does not work.There was no patient involved.
Additional Manufacturer Narrative
Corrected data: b5, b6, b7, d10, h6(clinical and impact code) updated data: b4, e1 (initial reporter), e2, e3, g3, g6, h2, h10, h11.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.Could not replicate failure.Equipment undergoing testing for several days.Functional tests.Equipment suitable 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).
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 17860468
• Report Number: 2249723-2023-04308
• Device Sequence Number: 14885495
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: (01)10607567107691(21)SA03014-I4
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K031636
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 01/29/2024; 09/25/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/12/2023; 01/29/2024; 09/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2004
• 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: N/A.; UNKNOWN.
• Patient Sex: Unknown