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

Model Number N/A

Device Problems Mechanical Problem (1384); Date/Time-Related Software Problem (2582)

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

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 getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was unable to duplicate the reported issues.The fse replaced the front end board as a precaution.The fse also replaced the safety disk, as it was expired.The iabp unit passed all calibration, functional and safety tests performed.The unit was returned to the customer and cleared for clinical use.

Event Description

It was reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced timing errors, pumping timing was off.No patient harm or adverse event was reported.

Event Description

It was reported that while in use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced timing errors, pumping timing was off.No patient harm or adverse event was reported.

Manufacturer Narrative

The removed front end board was returned to the getinge national repair center (nrc) for further investigation.A senior repair technician inspected the front end board and no visual damage was observed.The technician installed the board into a cs300 test fixture and tested to factory specifications per cs300 service manual.Testing passed and the reported failure "timing errors" could not be verified.The front end board was sent to the supplier for further analysis per procedure.The supplier returned the board to the nrc and reported that the reported failure was verified.They replaced the defective u38 and the board passed all of their testing.The technician at the nrc then installed the board into a cs300 test fixture and tested to factory specifications per cs300 service manual.The technician inspected the board per procedure and testing passed.The front end board was subsequently put into inventory/stock.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7748301
• MDR Text Key: 116081590
• Report Number: 2249723-2018-01322
• Device Sequence Number: 0
• Product Code: DSP
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/10/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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?: Yes
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1