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

Catalog Number 0998-00-3023-53

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2017

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.

Event Description

The customer reported that the cs300 intra-aortic balloon pump (iabp) while in use on a patient an auto fill issue occurred.There was no patient injury, death or adverse event reported.

Manufacturer Narrative

09/22/2017 02:25 pm (gmt-4:00) added by (b)(6) (pid-(b)(4)): the getinge field service engineer (fse) evaluated the intra-aortic balloon pump (iabp) and received an (etf) electrical test fails code # 53 indicating that the shuttle transducer value was out of range.So the fse replaced the shuttle transducer.The iabp successfully passed all calibration, functional and safety tests according to factory specifications.The iabp was returned to the customer and cleared for clinical use.

Event Description

The customer reported that the cs300 intra-aortic balloon pump (iabp) while in use on a patient an auto fill issue occurred.There was no patient injury, death or 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: 6830468
• MDR Text Key: 84127997
• Report Number: 2249723-2017-00376
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: Health Professional
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1