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

Model Number	0998-UC-3013-69
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) requires replacement parts.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Initial reporter name and address: (b)(6).
Additional Manufacturer Narrative
The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) replaced the batteries to fix the issue and performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The pm was completed and the iabp was then released and cleared for clinical service.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,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: 15735208
• Report Number: 2249723-2022-02837
• Device Sequence Number: 20413565
• Product Code: DSP
• UDI-Device Identifier: 10607567112596
• UDI-Public: 10607567112596
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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-UC-3013-69
• Device Catalogue Number: 0998-UC-3013-69
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2009
• 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: UNKNOWN.
• Patient Sex: Unknown