MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-69
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use during routine checks, the cs100 intra-aortic balloon pump (iabp) doesn't cycle and is making noise.There was no damage to patients.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine checks, the cs100 intra-aortic balloon pump (iabp) doesn't cycle and is making noise.There was no patient involved.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that they found the 5000 hour kit and safety disk were expired.The fse replaced both parts.After the parts were replaced, the equipment was tested and did not show any abnormality in its operation.The balloon was set into service mode and an inspection was performed where all parameters are in accordance with the tests established by the factory.The equipment stayed testing for more than 2 hours and did not show any more failures.The equipment was released for use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 110V
• 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: 20517367
• Report Number: 2249723-2024-0004362
• Device Sequence Number: 7880921
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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
• Report Date (Section B): 11/15/2024

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: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 11/15/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown