MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number	0998-00-3023-57
Medical Device Problem Codes	Inability to Auto-Fill (1044); Pressure Problem (3012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse replaced the drive manifold and safety disk.The iabp unit was cleared for clinical use and released to the customer.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a drive manifold issue.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.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10, h11.Corrected fields: b5, e1(event site telephone), h6(device codes).
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had an autofill error.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.

• Brand Name: CS300
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10851854
• Report Number: 2249723-2020-01919
• Device Sequence Number: 11832878
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: 10607567108254
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063525
• 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): 12/10/2020

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 Catalogue Number: 0998-00-3023-57
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1