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

Catalog Number	0998-00-3013-55
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm was unable to reproduce the issue.The stm replaced the main board, and the issue was resolved.The stm 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.The initial reporter named is a getinge employee whose contact details are: (b)(6), which differs from that of the event site.The full name is (b)(6).
Event or Problem Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs100 intra-aortic balloon pump (iabp) nv ram on the main board was not keeping data correctly.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, e1, g4, g7, h2, h6(evaluation method codes), h10.
Event or Problem Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs100 intra-aortic balloon pump (iabp) nv ram on the main board was not keeping data correctly.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs100 intra-aortic balloon pump (iabp) nv ram on the main board was not keeping data correctly.There was no patient involvement, and no adverse event 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: 10662489
• Report Number: 2249723-2020-01659
• Device Sequence Number: 4043678
• Product Code: DSP
• UDI-Device Identifier: 10607567108650
• UDI-Public: 10607567108650
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/10/2021

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 Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 02/10/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/20/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1