MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number	865241
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer and performed troubleshooting, which confirmed that the device was producing a yellow alarm for the invasive pressure parameter art wave, when it should produce a red alarm.A field service engineer (fse) was requested to reconfigure the monitor, but the customer resolved the issue before the fse arrived.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
Philips received a complaint on the intellivue mx700 patient monitor indicating that the art alarm was ringing as a yellow alarm when it should have been red.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue mx700 patient monitor indicating that the art alarm was ringing as a yellow alarm when it should have been red.The device was in use on patient at time of event, there was no adverse event reported.A philips remote service engineer (rse) spoke to the customer and performed troubleshooting, which confirmed that the device was producing a yellow alarm for the invasive pressure parameter art wave, when it should produce a red alarm.A field service engineer(fse) was requested to reconfigure the monitor.The fse provided information to the customer explaining the configuration of the patient monitor was set to "take settings" from the x2, explaining why there was no alarm on the monitor for the invasive pressure.The customer resolved the issue before the fse arrived; therefore, it was not able to be confirmed.Clinical audit logs and configuration files were requested but were not provided.Based on the information available, the cause of the reported problem was configuration of the monitor.The reported problem was not confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The manufacturing date for the reported device is prior to 24sept2016 so no udi required.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX700 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 19509808
• Report Number: 9610816-2024-00327
• Device Sequence Number: 19681652
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 865241
• Device Catalogue Number: 865241
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2014
• 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
• Patient Sex: Unknown