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

Model Number	0998-00-3013-64
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after use that the cs300 intra-aortic balloon pump (iabp) screen turned white following a shock.The complainant folded the screen down onto the cables, the shock occurred at the the end of the procedure when it was time to put away the equipment.No patient involvement or no harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they replaced the screen and the unit passed all functional and safety tests.Suspect device originally distributed as a cs100, upgraded to cs300 using conversion kit.Udi information provided for original model/catalog, as per product labeling.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 19680373
• Report Number: 2249723-2024-02748
• Device Sequence Number: 3212571
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: (01)10607567107509(21)SA05654F6
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 09/27/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/05/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2006
• 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