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

Catalog Number 0998-00-3023-53

Device Problem No Display/Image (1183)

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 complaint of the ecg waveform disappearing.The ecg waveform continuously displayed while using the trainer as well as the minisism simulator.The voltage for the ecg was checked and was within specs.The only issue the fse discovered was that the resistance on the customer's ecg cable was significantly higher than the new ones the fse has.It was recommended that the customer replace the ecg cable.In addition, the fse was unable to duplicate the "pump stopping" problem but noticed different triggers used on the date of the reported event.The fse replaced the blood detect tubing which broke while performing the blood detect test.Gasket retrofit and software update field action were also completed at the same time during this repair.The iabp unit was tested for functionality, performance and safety are all within specs.The unit was released for medical use.The facility's representative was not available at the time the evaluation was completed.The fse separated the ecg cable from the iabp unit and handed it over to the nurse at the front desk, with a note on the unit stating that the cs300 tested ok, but the ecg cable needed replacement.

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) ecg waveform and pump action disappeared from the screen while in use.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: 7134710
• MDR Text Key: 95604549
• Report Number: 2249723-2017-01036
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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