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

Model Number N/A

Device Problems Image Display Error/Artifact (1304); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2017

Event Type  malfunction  

Manufacturer Narrative

The customer has not requested getinge to evaluate the iabp. However, the customer has advised that the lcd display was replaced and the iabp was returned to clinical service.

Event Description

The customer reported that while the cs300 intra-aortic balloon pump (iabp) was in use on a patient, it experienced a mechanical problem causing the screen to continuously flicker. There was no adverse event reported.

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. At this time, the customer has not requested getinge to evaluate the iabp. Additional information has been requested from the customer with regard to the repair and status of the iabp, and a supplemental report will be sent if this information is provided to us.

Event Description

The customer reported that while the cs300 intra-aortic balloon pump (iabp) was in use on a patient, it experienced a mechanical problem causing the screen to continuously flicker. There was no adverse event 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: 7061648
• MDR Text Key: 104058091
• Report Number: 2249723-2017-00868
• 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

• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse