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

Catalog Number	0998-UC-3013-45
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor's field service engineer (fse) was dispatched to evaluate the iabp unit.The power supply to the motor control board cable and the mainboard to the motor control board cable were checked.The cables were good.The fse found the motor controller board to be faulty and replaced.It.The iabp was returned to the customer and cleared for clinical use.The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.
Event or Problem Description
It was reported that the day after the cs100 intra-aortic balloon pump (iabp) was installed an error code # 50 for the electrical safety test failure occurred.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that the day after the cs100 intra-aortic balloon pump (iabp) was installed an error code # 50 for the electrical safety test failure occurred.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10.

• 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: 10792651
• Report Number: 2249723-2020-01820
• Device Sequence Number: 14344972
• 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
• Report Date (Section B): 12/04/2020

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 Catalogue Number: 0998-UC-3013-45
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1