MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER

Model Number	862442
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
Customer reported that sp02 measurement does not match at all with the mock monitor or the other monitor in the room and sp02 sensor was also replaced.Patient involvement is unknown.There was no report of patient or user harm.
Event or Problem Description
Customer reported that sp02 measurement does not match at all with the mock monitor or the other monitor in the room despite the sp02 sensor being replaced.Patient involvement is unknown.There was no report of patient or user harm.The unit was returned for evaluation.No issues were found with the unit and the reported problem could not be confirmed.
Event or Problem Description
Philips received a complaint on the intellivue multi measurement server sn (b)(6) indicating the sp02 measurement did not match at all with the mock monitor or the other monitor in the room despite the sp02 sensor being replaced.The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.
Additional Manufacturer Narrative
This supplemental report is submitted for additional information with reference to manufacturer's report number 9610816-2023-00110.The customer sent the unit to bench for evaluation.The following functional tests were performed: the spo2 sensor was tested with the fluke prosim 8 vital sign simulator, fluke esa620, electrical safety analyzer, and fluke 179 digital multimeter.Results of functional testing confirmed: the spo2 measurement worked perfectly.The carried out measurements registered accurately.Every other function of this device worked flawlessly.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The bench repair unit provided functional testing to measure the accuracy of the spo2 sensor; however, the results could not confirm any issues with the measurements.The unit was sent back to the customer.The device remains at the customer site.No subsequent calls have been logged for this device/issue.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER
• Common Device Name: INTELLIVUE MULTI 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16494870
• Report Number: 9610816-2023-00110
• Device Sequence Number: 6296631
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: 00884838000254
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122439
• 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,Followup,Followup

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: 862442
• Device Catalogue Number: 862442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 02/08/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/15/2023; 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2006
• 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