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

Model Number	0998-00-3013-68
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.The full name of the event site was shortened due to field character limit; the full name is: (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a helium leak and a low vacuum.It is unknown under which circumstances this event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Testing of actual/suspected device: (10) a getinge field service engineer (fse) evaluated the iabp and found that the iabp when operation at times presents a message on the bottom screen: vacuum activating the alarm.The iabp motor parts were changed previously.The fse changed the kit parts 5000 hours of the motor; however the iabp remained in error.The fse placed the solenoid control board, the error persisted.The fse then placed a test manifold actuator and the equipment returned to functioning normally.General cleaning was done on the equipment.The iabp was not released for clinical use.A supplemental report will be submitted if additional information is provided.
Additional Manufacturer Narrative
Testing of actual/suspected device (213): the unit passed all functional and safety tests per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b6, b7, g4, g7, h2, h6(investigation type, investigation findings & investigation conclusions), h11.Corrected fields: g1(contact person), h10.A getinge field service engineer (fse) evaluated the iabp and found that the iabp when operation at times presents a message on the bottom screen: vacuum activating the alarm.The iabp motor parts were changed(they were due for change due to hours) but could be a potential for the failure to occur.The fse changed the kit parts 5000 hours of the motor; however the iabp remained in error.The fse placed the solenoid control board, the error persisted.The fse then placed a test manifold actuator and the equipment returned to functioning normally.General cleaning was done on the equipment.The iabp was not released for clinical use during this visit.The fse returned with the replacement part and replaced the manifold actuator and the equipment is functionally normally and was released for clinical use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11900431
• Report Number: 2249723-2021-01113
• Device Sequence Number: 4247393
• Product Code: DSP
• UDI-Device Identifier: 10607567108698
• UDI-Public: 10607567108698
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2022

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: Other
• Device Model Number: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 12/01/2021; 06/21/2022
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 06/23/2021; 12/23/2021; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose