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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) was dispatched to evaluate this unit and was able to reproduce the reported failure.The fse reproduce the issue, with both system trainer and patient simulator connected.The fse replaced the front end board and ecg cable without resolution of complaint so he reinstalled customer¿s original and provided the customer with helium knobs.The fse went back to the facility and replaced the main board and ecg lead fault message remained with both the system trainer and patient simulator in use.The fse continued troubleshooting and replaced front end board as well.The ¿ecg lead fault¿ message cleared once main board and front end board were replaced.The fse then performed a full calibration and functional test as per factory specifications.The iabp was then returned to customer and cleared for clinical use.(b)(6).

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) presented ecg fault related issue.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The suspected defective front end board was returned to getinge's national repair center (nrc) for failure analysis.A senior repair technician inspected the front end board and no visual damage was observed.The front end board was then installed into the cs300 test fixture and was tested to factory specifications per the cs300 service manual.The front end board failed testing, and the reported failure was verified - the ecg lead fault message is displayed with a triggering ecg.The front end board is being send to the supplier for failure analysis per procedure.In addition, the suspected defective main board was returned to getinge's national repair center (nrc) for failure analysis.A senior repair technician inspected the main board and no visual damage was observed.The main board was then installed into the cs300 test fixture and was tested to factory specifications per the cs300 service manual.The main board passed testing, and the technician was unable to verify the reported failure.There is no ecg lead fault message displayed with a triggering ecg.However, the main board is being sent to the supplier per procedure.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) presented ecg fault related issue.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The supplier evaluated the front end board and verified the reported failure.They replaced defective t1 and u72 and the board passed all of their testing.The board was then returned to getinge's national repair center (nrc) and a senior repair technician installed the board into cs300 test fixture and tested it to factory specifications per the cs300 service manual.The board passed testing, but was scrapped due to it being obsolete.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) presented ecg fault related issue.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) presented ecg fault related issue.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The main board was returned from the supplier to the national repair center (nrc), and the supplier could not verify the reported failure.The main board passed all of their testing and they replaced damaged jp31 connector and performed (b)(4).A senior repair technician of the nrc installed the main board into a cs300 test fixture and tested it to factory specifications per cs300 service manual.The main board passed testing, but has been scrapped as this board is now obsolete.

• 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: 7909856
• MDR Text Key: 122001610
• Report Number: 2249723-2018-01658
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2019

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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 12/21/2018; 01/17/2019
• Supplement Dates FDA Received: 11/20/2018; 01/11/2019; 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1