MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FORESIGHT ELITE PREAMP CABLE

Model Number 01-06-3101

Device Problems Incorrect Measurement (1383); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The foresight preamp cable was received for product evaluation.The suspect cable was connected to a known good working elite monitor for testing along with simulators.The readings obtained were low, 10-20%.They fluctuated up to the 80¿s when the cable was flexed.Further testing found low brain signals for three wavelengths.Internal inspection of the shielding on the preamp printed circuit board found that there was a 30 gauge shield buss wire that was broke.A new buss wire was installed.Testing was done with the new buss wire and there were no further fluctuation of values.The inaccurate values received did not occur in a clinical setting.The information was obtained when the product had been returned for evaluation for testing in the service center.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue was not confirmed by evaluation; however, inaccurate values were received during product evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.With any hemodynamic monitoring readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.It is unknown if user or procedural factors contributed to the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of the monthly review.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that the foresight elite preamp cable will not provide any values during patient monitoring.The connections were checked and they were secure.They removed the suspect cable and connected to a different monitor for testing and received the same issue.They exchanged the suspect cable for a different cable and then everything worked.They were unable to obtain the values.There was no patient harm or injury.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: FORESIGHT ELITE PREAMP CABLE
• Type of Device: FORESIGHT ELITE PREAMP CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9378720
• MDR Text Key: 188708336
• Report Number: 2015691-2019-04417
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• PMA/PMN Number: K143675
• 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: 10/17/2019

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 Expiration Date: 04/03/2022
• Device Model Number: 01-06-3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1