MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ITALIAN,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-67
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.Fse troubleshot unit and found and replaced defective condensate removal module and then performed regular operation tests.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted upon completion of our investigation.The full event site address in was shortened due to field character limit; the full address is (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a helium leak.It is unknown under which circumstances this occurred; however there was no harm or injury to patient and no adverse event was reported.
Event or Problem Description
It was reported that before use the cs100 intra-aortic balloon pump (iabp) had a helium leak.There was no patient involved and no adverse event was reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ITALIAN,NON-UTS,INTL
• 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: 12843023
• Report Number: 2249723-2021-02690
• Device Sequence Number: 4080843
• Product Code: DSP
• UDI-Device Identifier: 10607567108681
• UDI-Public: 10607567108681
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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-UC-3013-67
• Device Catalogue Number: 0998-UC-3013-67
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 03/09/2022; 10/18/2023
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 03/31/2022; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown