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

Model Number N/A

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that during an operation test before shipment, a company representative field service engineer (fse) confirmed that the valve (k6,k6a,k7,k8) had an out of range value, the cart handle was loose, and the screwthread fixing the handle was broken.This is an out of box (oob) issue.There was no patient involvement, and there was no adverse event reported.

Manufacturer Narrative

The getinge field service engineer (fse) performed the repair in the getinge office.The cart handle was fixed and the drive manifold and datasettes were replaced.The running test passed with no reported incident.The iabp was cleared for clinical use.

Event Description

It was reported that during an operation test before shipment, a company representative field service engineer (fse) confirmed that the valve (k6,k6a,k7,k8) had an out of range value, the cart handle was loose, and the screwthread fixing the handle was broken.This is an out of box (oob) issue.There was no patient involvement, and there was no adverse event reported.

Event Description

It was reported that during an operation test before shipment, a company representative field service engineer (fse) confirmed that the valve (k6,k6a,k7,k8) had an out of range value, the cart handle was loose, and the screwthread fixing the handle was broken.This is an out of box (oob) issue.There was no patient involvement, and there was no adverse event reported.

Manufacturer Narrative

The faulty drive manifold was returned to the getinge national repair center (nrc) for further investigation.During visual inspection, the getinge technician found that the pressure transducer was removed and its hardware was missing.In order to reproduce the failure, the suspect drive manifold was installed in the cs100 test fixture.K6, k6a, k7, k8 leak test was performed and failed test 1 and 3 intermittently.The drive manifold k6, k7 and k8 were inspected.K6, k6a, k7, k8 leak test were performed ten times (10x) and all tests passed successfully.The device was functioning properly after k6, 7, and 8 were inspected.It was possible that one of the valves were getting stuck.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7711721
• MDR Text Key: 114941069
• Report Number: 2249723-2018-01237
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1