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

Model Number N/A

Device Problem Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was unable to duplicate the issue.As a precautionary measure, the fse replaced the batteries.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had an issue with the battery.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had an issue with the battery.There was no patient involvement, and no adverse event reported.

• 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: 11379850
• MDR Text Key: 234221068
• Report Number: 2249723-2021-00411
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1