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

Catalog Number 0998-00-3023-53

Device Problem Inaccurate Synchronization (1609)

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

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company 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 upon initial inspection, found no damage to the ecg input port or the pressure input.The fse connected the leads from the anesthesia to a patient simulator and the ecg cable from the anesthesia to the input on the balloon pump in question.The ecg signal showed up immediately and the fse was able to control the beats per minute from the simulator and see the change immediately on the balloon pump.The fse found no issue with the cable or the balloon pump and was unable to reproduce the problem.The fse suggests, perhaps the customer had the ecg cable connected to the ecg output port on the balloon pump.Both ports are very close together and it is an easy mistake to make as the labeling is hard to read from standing because the safety disk blocks the view.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.

Event Description

The customer stated that while the intra-aortic balloon pump (iabp) was being used on a patient, the device would not sync to the ge anesthesia unit for ecg waveforms.When slaved to the patient monitor and anesthesia unit, no ecg was showing up on the balloon pump monitor.The biomed team had checked the unit and found it to be working properly, but the doctor requested they call maquet for further testing of unit.There was no 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: 6706402
• MDR Text Key: 80019870
• Report Number: 2249723-2017-00082
• 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
• Report Date: 07/11/2017

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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