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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and explained that the monitor measures map using an algorithm that analyzes the oscillation envelope and computes systolic, diastolic, and mean pressures, whereas manual calculations often use a rule of thumb formula (map = [2 × diastolic + systolic] / 3), which is less accurate.The rse provided educational material to clarify this difference.Biomed voiced understanding and was advised to share the information with nursing staff.The system met specifications and was returned to use.No device failure was found, and no error codes were encountered.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the earlyvue vs30 indicating that that clinical staff were questioning the difference between the vs30 monitor's measured map (mean arterial pressure) and manually calculated values.The device was in use on patient at time of event, there was no adverse event reported.

• 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: 25348172
• Report Number: 9610816-2026-101028
• Device Sequence Number: 10743465
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/01/2026

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: 05/19/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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