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

Model Number	N/A
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted when additional information is provided.
Event or Problem Description
It was reported that upon power up and prior to use, the display for the cs100 intra-aortic balloon pump (iabp) was not visible.The end user restarted the power supply three (3) times but the conditions did not improve.It was noted that after percutaneous coronary intervention (pci) was completed, the iabp unit was powered on again and the iabp unit display did not have any issues.There was no patient involvement, and no adverse event was reported.
Event or Problem Description
It was reported that upon power up and prior to use, the display for the cs100 intra-aortic balloon pump (iabp) was not visible.The end user restarted the power supply three (3) times but the conditions did not improve.It was noted that after percutaneous coronary intervention (pci) was completed, the iabp unit was powered on again and the iabp unit display did not have any issues.There was no patient involvement, and no adverse event was reported.
Additional Manufacturer Narrative
After the event, the iabp unit was able to be booted up normally by the physician and the display was observed to be working properly.A getinge field service engineer (fse) evaluated the iabp unit and was unable to duplicate the reported issue.As a precautionary measure, the video receiver board and the display cable were replaced.All connections were confirmed and re-connected between the connectors.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
Event or Problem Description
It was reported that upon power up and prior to use, the display for the cs100 intra-aortic balloon pump (iabp) was not visible.The end user restarted the power supply three (3) times but the conditions did not improve.It was noted that after percutaneous coronary intervention (pci) was completed, the iabp unit was powered on again and the iabp unit display did not have any issues.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: 10573288
• Report Number: 2249723-2020-01538
• Device Sequence Number: 1217847
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: 10607567108674
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/05/2021

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: 0998-00-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 12/17/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/12/2020; 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1