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

Model Number	N/A
Medical Device Problem Codes	Overheating of Device (1437); Pumping Stopped (1503)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse confirmed the fans were dirty.A general cleaning of the iabp was performed and then preventative maintenance was performed as required with replacement of the drive assembly with a used part as requested and provided by the customer due to leaking observed in k6, k7, k8.The iabp unit passed all pm tests after replacement of pm parts, and all other functional and safety tests were also passed per specifications.The iabp was cleared for clinical use and released to the customer.(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 (b)6) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.
Event or Problem Description
Customer reported that after a few hours of operation, the cs100 intra-aortic balloon pump (iabp) turned off due to overheating.It is unknown if there was a patient involved during the operation of the iabp; however, no adverse event was reported.
Event or Problem Description
Customer reported that after a few hours of operation, the cs100 intra-aortic balloon pump (iabp) turned off due to overheating.It is unknown if there was a patient involved during the operation of the iabp; however, 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: 10511340
• Report Number: 2249723-2020-01454
• Device Sequence Number: 1270564
• 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: 11/05/2019
• Supplement Date Received by Manufacturer: 09/24/2020
• 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