MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH EarlyVue VS30; Oximeter

Model Number	EarlyVue VS30 Vitals monitor
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an earlyvue vs30 monitor indicating that the spo2 was not reading correctly.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
A philips technical consultant (tc) went to the customer site.The tc found that the inaccurate spo2 readings were associated with the third-party cable.The underlying internal reason the third-party cable produced inaccurate readings was not determined.Following installation of the philips-supplied spo2 cable, the vs30 was retested using the same test equipment.The monitor produced accurate and consistent spo2 readings, confirming proper monitor operation.No additional issues were identified during testing.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was a third part cable issue.Installation of a philips-supplied spo2 cable resolved the issue.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the service history for this device found no additional reports submitted for this device related to the reported issue.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.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: 50918153
• Report Number: 9610816-2026-102022
• Device Sequence Number: 5777036
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/28/2026

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: 09/18/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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