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

Model Number N/A

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per sop 01-061 since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate this unit.The stm confirmed customer issue in logs and was able to reproduce issue once upon arrival but could not duplicate issue after initial alarm.The stm completed condensation removal procedure, re-terminated internal vacuum pneumatic connections, and replaced crm module as a precaution.The stm then, completed calibration check, functional testing and safety check to factory specifications.The unit passes all functional checks was returned to the customer and cleared for clinical use.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) generated a low vacuum alarm.It is unknown under which circumstances this event occurred; however, there was no patient involvement and no adverse event was reported.

Event Description

It was reported that during setup, the cs300 intra-aortic balloon pump (iabp) generated a low vacuum alarm.There was no patient involvement and no adverse event was 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: 7735195
• MDR Text Key: 115648311
• Report Number: 2249723-2018-01275
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1