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

Model Number	862442
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the intellivue multi measurement server provided spo2 readings that were inaccurately high for a ventilated patient.The device was in use monitoring a patient at the time of the reported issue.No death or patient / user injury or harm was reported.
Additional Manufacturer Narrative
Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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
The customer reported that the intellivue multi measurement server provided spo2 readings that were inaccurately high for a ventilated patient, resulting in the patient becoming hypoxic.The device was in use monitoring a patient at the time of the reported issue.A serious injury was reported.
Additional Manufacturer Narrative
At the time of the event, the customer reported the spo2 cables were connected to an mp70 along with the spo2 sensor on the patient's finger.It was unknown if the waveform and signal quality appeared to be good, when spo2 was gave a false high reading.The biomed (bmed) tested the unit onsite and could not confirm the customer's allegations.The unit functioned as intended along with the spo2 sensor and spo2 cables.The device worked to specification with no errors.

• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 16767718
• Report Number: 9610816-2023-00173
• Device Sequence Number: 3251785
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: 00884838000254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• 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?: Yes
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 04/27/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/20/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown