MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS SURESIGNS VS3; ALARM, BLOOD-PRESSURE

Model Number VS3

Device Problems Nonstandard Device (1420); Application Program Problem (2880)

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

Event Date 05/10/2019

Event Type  Injury  

Event Description

Philips medical sent out two (2) recalls on the vs3 and vs4 monitors.The software was to patch a battery issue (fsn86000266a) and spo2 issue (z-1317-2019).The software update then locked all monitors that were using non-philips batteries.For our organization, it would make 1183 devices non-functional.This would create a serious safety issue for our healthcare facilities.Additionally, the details regrading this change were not fully disclose.We have stopped installing the upgrades believing that the risk of losing these monitor was greater than the safety improvement from the upgrade.This appears to be a restriction of trade rather than a true recall.Test date: (b)(6) 2019.Monitor non-functional after installation of software.Fda safety report id # (b)(4).

• Brand Name: PHILIPS SURESIGNS VS3
• Type of Device: ALARM, BLOOD-PRESSURE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 8645997
• MDR Text Key: 146475294
• Report Number: MW5086924
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• 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: 05/22/2019
• 2 Devices were Involved in the Event: 1 2

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 Model Number: VS3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2019
• 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): Required Intervention