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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.E1 event site address was shortened due to character limitations.The complete address is (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) was not cycling.There was no harm reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit and performed inspection on the pump.First, the fse found that the shuttle transducer was out, and a calibration attempt was made without success.The transducer was replaced and a new calibration was carried out which the equipment worked normally again.The safety disk and the vacuum/pressure motor kit 5000 were also replaced.After all changes, the equipment was tested for more than 2 hours and did not show any abnormality in its operation, equipment released for use.
Event or Problem Description
It was reported that during pre-use testing, the cs100 intra-aortic balloon pump (iabp) was not cycling.There was no patient involvement.
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: 18836021
• Report Number: 2249723-2024-00926
• Device Sequence Number: 20716154
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: (01)10607567107691(21)SA314637K9
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/18/2024

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: 02/23/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 03/18/2024; 04/04/2024; 10/18/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/18/2024; 03/20/2024; 04/05/2024; 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown