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

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

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

Event Description

It was reported that while in use on a patient, a "low vacuum" message was observed on the screen of the cs300 intra-aortic balloon pump (iabp) by the end user.The getinge representative recommended the end user to change the iabp and refer it to clinical engineering.Customer agreed to exchange the iabp.No patient injury or adverse event was reported.

Event Description

It was reported that while in use on a patient, a "low vacuum" message was observed on the screen of the cs300 intra-aortic balloon pump (iabp) by the end user.The getinge representative recommended the end user to change the iabp and refer it to clinical engineering.Customer agreed to exchange the iabp.No patient injury or adverse event was reported.

Manufacturer Narrative

Good faith efforts (gfe) attempts were made to the customer to obtain additional information on this complaint event.The customer's biomedical engineer reported that they were able to reproduce the reported issue.A 2500h pm kit was installed to fix the issue, and the iabp was cleared and back for clinical service.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9298562
• MDR Text Key: 190677189
• Report Number: 2249723-2019-01781
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 136