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

Model Number	0998-00-3013-67
Medical Device Problem Codes	Inability to Auto-Fill (1044); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use on a patient, the cs100 intra-aortic balloon pump (iabp) had an ekg signal anomaly and the aortic balloon failed to fill.There was no patient involved.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4,d9, g3, g6, h2, h3, h4, h6 type of investigation, investigation findings, component codes, investigation conclusions, h11.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and was able to confirm the reported issues.The fse replaced the ecg input to front end cable assy, ecg trunk cable and ecg lead wire set to resolve the ecg trigger / signal - difficult to obtain / malfunction and the fse solved the reported problem of autofill failure, eliminated leak on the vacuum quick coupling that connects to the pump.Operational tests performed with a positive outcome.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 20505873
• Report Number: 2249723-2024-0004330
• Device Sequence Number: 8296358
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486(10)SA101554H7
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2007
• 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.
• Patient Sex: Unknown