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

Model Number	N/A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse performed an inspection.The vacuum pump was disassembled and found the pressure block needed replacing because the air ventilation was dirty and overheating was occurring.The vacuum hose, vacuum/pressure compressor and pressure hose were ordered to be replaced.All final tests were passed to factory specifications, and the unit released for use as all tests in the service mode were passed, cycle tests were run for 45 minutes and also passed.(b)(6).It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge brazil has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had electrical error 50 and switching off alone.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had electrical error 50 and switching off alone.It is unknown the circumstances under which the event occurred; however there was no patient involvement and no 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: 10509853
• Report Number: 2249723-2020-01448
• Device Sequence Number: 1269953
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-68
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1