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

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the iabp unit has not been provided to us.However, we are seeking additional information, and if received, we will submit a supplemental report.(b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) iabp indicated "rapid gas loss", and after changing the iabp, the alarm no longer occurred- the balloon catheter was ok.The circumstance of the event is unknown; however, no patient adverse event was reported.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) iabp indicated "rapid gas loss", and after changing the iabp, the alarm no longer occurred- the balloon catheter was ok.The circumstance of the event is unknown; however, no patient adverse event was reported.

• Brand Name: CS100
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10478415
• Report Number: 2249723-2020-01399
• Device Sequence Number: 2578169
• Product Code: DSP
• UDI-Device Identifier: 10607567112671
• UDI-Public: 10607567112671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: N/A
• Device Catalogue Number: 0998-00-3013-61
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1