MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30; OXIMETER

Model Number	EARLYVUE VS30 VITALS MONITOR
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the earlyvue vs30 vitals monitor indicating that the non-invasive blood pressure (nibp) was showing high in the simulator.The device was not in use on a patient at the time of the event, so there was no patient involvement.
Additional Manufacturer Narrative
Analysis was performed by philips remote service engineer (rse), who spoke to the customer.The customer called in stating that the nibp readings on a vista/vm monitor were consistently higher than expected during testing.The customer was setting the simulator to 120/80; however, the monitor was consistently displaying readings of approximately 120/90, with the diastolic value reading about 10 mmhg high.The customer confirmed that the same simulator was tested on other monitors and produced accurate results.The issue appeared to be isolated to this particular monitor, as the elevated diastolic readings were consistently reproducible on this device.Based on the results of the analysis, it was determined that the product has malfunctioned, and the likely cause of the reported problem was the nibp pump.The rse provided the part identification for the nibp pump.The customer advised he would be placing the order for the nibp pump.

• Brand Name: EARLYVUE VS30
• Common Device Name: OXIMETER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 25671439
• Report Number: 9610816-2026-101273
• Device Sequence Number: 12161817
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K190624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EARLYVUE VS30 VITALS MONITOR
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown