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	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nbp bottom number (diastolic) is 10 points too high compared to other devices.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer biomed who reported that the nbp bottom number (diastolic) is 10 points too high as compared to other vs monitors.The biomaed also stated that he has calibrated the non-invasive blood pressure (nbp) with like results and the device passes the nbp accuracy test.The rse advised the biomed that the vs30 uses the oscillometric method to determine nibp and that oscillometry has become the preferred method for automated noninvasive blood pressure (nbp) monitoring in most clinical settings.It is increasingly used as an alternative to the invasive blood pressure measurement.The rse also advised the biomed that if comparing a nbp pressure to another device that does not use this oscillometry method the measurements could vary.To promote accuracy, the nurses should use oscillatory devices that meet the association for the advancement of medical instrumentation standards when compared with auscultatory method.The biomed stated that he would follow up with their account manager to have them explain to the hospital management the oscillometric method to determine nibp.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 misunderstanding of the oscillometric method to determine nibp.The rse made three attempts to confirm the resolution, but there was no response from the customer.

• 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: 25354154
• Report Number: 9610816-2026-101064
• Device Sequence Number: 10646237
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2022
• 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