EARLYVUE VS30 VITALS MONITOR
Received Dec 15, 2025 · Event occurred Dec 8, 2025
Report 9610816-2025-001226 · MDR key 23810151
Device
Generic name
Oximeter
Manufacturer
Philips Medizin Systeme Böblingen GmbhModel number
EARLYVUE VS30 VITALS MONITORCatalog number
863380
Product problems
- High Readings
- High Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE CUFF, AND SMALL PIN HOLES IN THE CUFFS. THE CUFFS AND TUBING WERE REPLACED TO RESOLVE THE ISSUE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DAMAGED CUFFS. THE REPORTED PROBLEM WAS CONFIRMED. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
Additional Manufacturer Narrative
PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 INDICATING THAT THE MACHINE WAS GIVING "SUPER HIGH" BLOOD PRESSURE READINGS. IT WAS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.