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

Catalog Number	0998-00-3013-45
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to reproduce the issue.The fse has not completed the maintenance, no parts have been replaced to date.The iabp has been taken out of clinical use.Additional information has been requested, and we will report accordingly if it becomes available.The full name of the event site was shortened due to field character limit; the full name is (b)(6).
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a negative pressure too low message.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6 (evaluation result codes, conclusion codes), h10.The getinge field service engineer (fse) completed the repair of the unit by replacing the drive manifold.The iabp returned to customer and cleared for clinical use.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a negative pressure too low message.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that before use, the cs100 intra-aortic balloon pump (iabp) generated a "negative pressure too low" alarm.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
After on-site inspection, the getinge field service engineer (fse) observed that the values of x1 and x2 sensors had a large deviation.It was judged that the k8 valve is faulty and would need to be replaced.

• 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: 10863339
• Report Number: 2249723-2020-01959
• Device Sequence Number: 17094540
• 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,Followup
• Report Date (Section B): 04/29/2021

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: Health Professional
• Device Catalogue Number: 0998-00-3013-45
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 04/29/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/24/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1