MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC HEMOSPHERE ADVANCED MONITOR (HEM1); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEM1

Device Problem Output Problem (3005)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

It seems that every post-surgical heart patient i have received since we have gotten the new edwards monitors has had an issue with monitoring mixed venous oxygen saturation (svo2).The svo2 initially reads, but after a while, the monitor alarms and the error message, "fault: oximetry cable temperature" pops up.I have tried with this patient, as with others, to unplug and re-plug the cord for the svo2.When you try to go into the "oximetry calibration" menu, all of the options are greyed out, so the monitor doesn't even give the user the option of recalling data or recalibrating.The issue has been in multiple rooms with multiple monitors.Manufacturer response for hemodynamic monitor, edwards lifesciences, (per site reporter).The vendor is aware and is reportedly working on a software update to remedy this problem for the last few months.

• Brand Name: HEMOSPHERE ADVANCED MONITOR (HEM1)
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• MDR Report Key: 9146031
• MDR Text Key: 160907195
• Report Number: 9146031
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA