MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS EARLYVUE VS30 VITAL SIGNS MONITOR; OXIMETER

Model Number EARLYVUE VS30

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

I have had a handful of calls regarding temperature error messages on our new vs-30 vital signs monitors, when i looked into the error log on one unit, i found several error messages code 868 temp error front end will reset itself, and code 866 temp probe error (22).I was advised to and send this first unit in for repair serial number (b)(4) front end assembly and predictive temp was replaced.Since then i have had one more unit with same issue, so i checked 5 more units and all have this issue.I have called tech support and they are not aware of any fco's or service bulletins.Fda safety report id # (b)(4).

• Brand Name: PHILIPS EARLYVUE VS30 VITAL SIGNS MONITOR
• Type of Device: OXIMETER
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 11100450
• MDR Text Key: 224855686
• Report Number: MW5098594
• Device Sequence Number: 1
• Product Code: DQA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/28/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EARLYVUE VS30
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other