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

Catalog Number 0998-00-3013-83

Device Problems Low Audible Alarm (1016); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge technical service representative reported that the solenoid driver board was determined to be the issue and needed to be replaced.The service rep replaced the solenoid driver board and the error cleared.The service rep performed full functional testing and all values were within limits.The service rep let the iabp run for 30 minutes and no errors came up.The iabp was released back to the customer and cleared for clinical use.(b)(6).

Event Description

A getinge service representative reported that while performing the functional test of recall 121 the cs100 intra-aortic balloon pump (iabp) started to alarm while in service mode.It was a constat alarm and the alarm listed in the "last faults" was fault code #54.The service rep restarted the unit and the alarm came up again.The solenoid driver board was recently changed for recall 118.The customer placed in an older board and the unit began to function normally.The solenoid driver board will need to be replaced.

• 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: 7014759
• MDR Text Key: 92738345
• Report Number: 2249723-2017-00767
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-3013-83
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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