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

Model Number N/A

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Additional information has been requested, and we will report accordingly when it becomes available.The full event site name is (b)(6) hospital.

Event Description

It was reported that after some tests were performed by a getinge field service engineer (fse), the cs100 intra-aortic balloon pump (iabp) generated error code #50.It was detected that the motor control pcb was defective and needed to be replaced.There was no patient involvement, and no adverse event was reported.

Manufacturer Narrative

A company representative has provided clarification on this complaint event and has been updated accordingly.In addition, the getinge fse later determined that the batteries of the iabp were completely discharged during the installation and that the motor controller board was not defective because the iabp worked fine when he attempted to replace the board.The fse tested the iabp for a further 24 hours without replacing the board and verified that it functioned appropriately and the error was not repeated.All calibration, functional and safety tests were performed, and the iabp passed per factory specifications.The iabp was released to the customer for clinical use.Since the motor controller board was not replaced, no failure analysis is necessary.

Event Description

It was reported that after some tests were performed during installation of the cs100 intra-aortic balloon pump (iabp) by a getinge field service engineer (fse), the iabp generated error code #50.It was detected that the motor control pcb was possibly defective and needed to be replaced.The clinical engineering technician and responsible physician at the facility was present when this issue occurred.There was no patient involvement, and no adverse event was reported.This is a possible out of box failure.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8035416
• MDR Text Key: 126222336
• Report Number: 2249723-2018-01915
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: BR
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-68
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1