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

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

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

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per sop (b)(4) since the serial number for the unit was not provided.Customer has not requested service from getinge.We have requested additional information from the customer, and we will report accordingly if the information is provided to us.

Event Description

Customer reported during patient use, the intra aortic balloon pump (iabp) generated "blood detected alarm".This was resolved after shutting off and rebooting the pump.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: 6789047
• MDR Text Key: 82772021
• Report Number: 2249723-2017-00267
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2017
• 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