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

Model Number	N/A
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to reproduce the reported issue.The fse determined that the issue was as a result of an over vacuum alarm.To fix the issue, the fse replaced the drive assembly, and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that during a routine inspection and testing of the cs100 intra-aortic balloon pump (iabp), the unit alarmed an issue of "negative pressure to low." there was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that during a routine inspection and testing of the cs100 intra-aortic balloon pump (iabp), the unit alarmed an issue of "negative pressure to low." there was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that during a routine inspection and testing of the cs100 intra-aortic balloon pump (iabp), the unit alarmed an issue of "negative pressure to low." there was no patient involvement, and no adverse event 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: 10993753
• Report Number: 2249723-2020-02126
• Device Sequence Number: 13647931
• Product Code: DSP
• UDI-Device Identifier: 10607567111957
• UDI-Public: 10607567111957
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2021

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: N/A
• Device Catalogue Number: 0998-00-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 01/25/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/22/2021; 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1