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	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that blood pressure not reading when set to low measurements.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 a philips remote service engineer (rse) which included interviewing the customer and assisting with the troubleshooting of the unit.The customer recalled testing the unit with a simulator.The unit should have alarmed when set to neonatal and 170/40.The customer noted the nbp was not providing correct readings under pediatric profile.When the unit was set to a pediatric profile and configured to 120/80 it does provide a reading.A philips remote clinical application specialist (cas) looked into the matter and worked with the customer to review both the neonatal and pediatric profiles.During testing using the neonatal setting on the simulator, no reading was produced; however, the results observed were accurate.Based on troubleshooting, the issue is likely related to the nbp pump, so the customer was provided replacement part information.The cas walked him through how to change to a neonatal profile, and they started a blood pressure.It would not register even in neonatal profile.The rse provided the customer with replacement part information for both the nbp pump and the main board.The customer elected to proceed with replacement of the nbp pump only.The rse subsequently attempted to follow up with the customer to determine whether the pump replacement resolved the issue; however, the customer could not be reached.No further follow-up has been received, and no additional complaints or service cases related to this issue have been reported.Based on the information available in the case and provided by philips personnel, the cause of the reported problem was confirmed to be the nibp pump.The alleged malfunction was 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: 25238224
• Report Number: 9610816-2026-100995
• Device Sequence Number: 13387205
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 05/21/2026

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: 04/23/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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