MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INELLIVUE MUTI MEASUREMENT SERVER

Model Number	M3001A
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer, and confirmed the reported issue.The sensor was replaced and cable checked, but there was no improvement.The rse determined that a device circuit board needed to be replaced.Based on the information available and the testing conducted, the cause of the reported problem was a faulty circuit board.The customer was provided a replacement circuit board to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.E1: reporting institution phone #: (b)(6).
Event or Problem Description
Philips received a complaint on an m3001a intellivue multi measurement server indicating that there was no spo2 measurement, and no technical alarm message displayed on the monitor.The device was not in clinical use at the time the issue was discovered.No adverse event or harm was reported.

• Brand Name: INELLIVUE MUTI MEASUREMENT SERVER
• Common Device Name: INELLIVUE MUTI MEASUREMENT SERVER
• 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: 21962873
• Report Number: 9610816-2025-000386
• Device Sequence Number: 15270121
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: (01)00884838000254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: M3001A
• Device Catalogue Number: M3001A
• 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: 04/25/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2021
• 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