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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the monitor's diastolic value was higher than expected.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 remote service engineer (rse) which included interviewing the customer and assisting with evaluating the unit.The customer explained they were performing preventative maintenance when using his simulator to test the monitor's nbp accuracy by applying specific nbp systolic and diastolic values to the monitor were higher than expected.To fix the problem, the customer decided to calibrate the monitor.The monitor passed the nbp accuracy test, but they still wanted to perform the nbp calibration.It was requested that the rse email him the nbp calibration instructions to his work email address.The rse informed the customer the monitor was under a parts warranty if the nbp pump or main board needed to be replaced.The customer stated they would reply by email should they need further assistance.The rse checked email on 03-sep-2026, and he found no response from customer.He also tried calling the customer and left a message for a call back when available.The rse sent an email to the customer with an excerpt from service guide listing nbp tests instructions.The customer received and reviewed the information.Both rse and customer discussed nbp calibration.The rse advised the customer on following service guide instructions and performing nbp calibration.The nbp calibration was successful.After the calibration completed the unit returned to working specification.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a need for calibration.The issue was resolved by calibrating the device and the product is back in service.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 ; +49(703)14632031
• MDR Report Key: 50877226
• Report Number: 9610816-2026-102003
• Device Sequence Number: 9379977
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/24/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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