MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX600 PATIENT MONITOR

Model Number	865242
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that they found the o2 saturation measurement to be not accurate.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Additional Manufacturer Narrative
Additional good faith effort to complete investigation is still pending at this time.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
H3 other text : not returned.
Event or Problem Description
The customer reported that they found the o2 saturation measurement to be not accurate.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.The philips representatives have not been able to obtain any additional information despite several requests being made.The cause of the event is unknown.It is unknown if the issue was resolved.The device remained on site.

• Brand Name: INTELLIVUE MX600 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX600 PATIENT MONITOR
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13401455
• Report Number: 9610816-2022-00052
• Device Sequence Number: 1687606
• Product Code: DSI
• UDI-Device Identifier: 00884838029095
• UDI-Public: 00884838029095
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K150310
• 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: Risk Manager
• 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
• Device Model Number: 865242
• Device Catalogue Number: 865242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/19/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 09/21/2022; 11/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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