MAUDE Adverse Event Report: DRE TRAX VITAL SIGNS / ETCO2 MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problems Loss of Power (1475); Failure to Power Up (1476); Problem with Software Installation (3013)

Patient Problem No Information (3190)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 we received a new trax co2 monitor from avante/dre medical which would not turn on.The unit was new from the mfr and had supposedly passed all of their "quality control" testing prior to shipment.I called the mfr rep, (b)(4), and requested a replacement.I was told it would ship out to us the next day.After a week or so i called and mentioned we had not received the unit and had a pt waiting to be set and was told it was shipping that day and we would have it by (b)(6).I called again on (b)(6) stating we still did not have the unit and was told it had already shipped and was scheduled for deliver on (b)(6).On (b)(6) i called again to inquire where the unit was and did not receive any type of answer.On (b)(6) a male from our company called and was told it had not shipped because of "some type of software glitch." on (b)(6) the unit was actually shipped.Upon receipt of the unit, another trax monitor we had out on a pt shut down and would not turn back on.This unit was just over 1 month old.Our rrt took the new unit and went to the pt's home to replace the malfunctioning unit, but the unit we had just received would not allow you to set and save the parameters.After about an hour, the rrt was able to get the older unit to turn back on, but there is obviously a quality issue with the monitors.I believe avante/dre is fully aware of the issue, but are only referring to it as "some type of software glitch," while still allowing the monitors out into the market for pt use.Co2 monitor would not power on.First device, unit purchased on (b)(6) 2019, put on a pt; second device, unit purchased as new that would not turn on; date of manufacture: 11/05/2018; third device, replacement that will not hold settings, date of manufacture: 05/06/2019.

• Brand Name: DRE TRAX VITAL SIGNS / ETCO2 MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• MDR Report Key: 8692823
• MDR Text Key: 148197315
• Report Number: MW5087305
• Device Sequence Number: 0
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other