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

Model Number N/A

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2018

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 company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) evaluated the iabp and found that the battery replacement date was not updated from the last time the batteries were replaced.To resolve the issue, the stm updated the replacement date in the system and ran the battery run test.The iabp ran for over 150 minutes before we turned the system off, and there was no occurring problem.All functional and safety tests were passed to factory specifications, and the iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) generated a "battery maintenance required" alarm, even after they ran the battery test, and that this issue already occurred once before and was resolved.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

• Brand Name: CS300
• 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: 7447347
• MDR Text Key: 106250062
• Report Number: 2249723-2018-00673
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2005
• 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