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

Catalog Number	0998-UC-3013-68
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.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)(4).
Event or Problem Description
It was reported that after performing a field action, the getinge service territory manager (stm) noted the cs100 intra-aortic balloon pump (iabp) had expired batteries, and safety disk.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h10.After further review, an initial emdr for this event was incorrectly submitted and the complaint had been created in error.There was no malfunction or adverse event reported and the event was simply an observation during service.As a result, no follow up emdr is necessary.Please cancel in your database.
Event or Problem Description
N/a.

• 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: 10691501
• Report Number: 2249723-2020-01708
• Device Sequence Number: 2875106
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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-UC-3013-68
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1