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

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) was dispatched to the customer's site.The fse inspected the unit and verified that there was a numeric value but no waveform for the ecg signal.After inspecting the iabp unit, the fse found that there was evidence of saline damage to the front end board.To fix the issue, the fse replaced the front end board and verified that the iabp unit would display both ecg and pressure numerics and waveforms.The fse then performed all functional and safety checks to meet factory specifications.The iabp unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The full event site name is (b)(6) hospital.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had no electrocardiography (ecg) trigger wave form.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had no electrocardiography (ecg) trigger wave form.No patient harm, serious injury or 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
• MDR Report Key: 8290309
• MDR Text Key: 134898326
• Report Number: 2249723-2019-00153
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• 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?: Yes
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1