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

Model Number	EARLYVUE VS30 VITALS MONITOR
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the unit is still not reporting correct vitals.Every temperature says 102 and systolic blood pressure (bp) reads 20 points higher.The device was not in use on a patient at the time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by a philips biomedical engineer (bmed) who went onsite to test the unit.Results of functional testing indicate the reported problem could not be replicated.Testing included a self-test and two test on patient simulators.The unit was within tolerance on each test.The bmed made sure tracker was correct in centrak.The unit has returned to service.Based on the information available in the case, the cause of the reported problem could not be replicated.The alleged malfunction was not confirmed.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 25326203
• Report Number: 9610816-2026-101052
• Device Sequence Number: 13221130
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/29/2026

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: 04/30/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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