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

Model Number	865241
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 invasive blood pressure (ibp) alarms reset themselves to "off" on the intellivue mx700 patient monitor despite being enabled in the settings.It is unknown if the device was in use monitoring a patient at the time of the reported issue.No adverse patient event was reported.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue mx700 patient monitor indicating that the invasive blood pressure (ibp) alarms were automatically reset to off-alarm status, despite being enabled in the settings.The following functional tests were performed: a field service engineer (fse) went onsite and was unable to observe any problem.The fse retrieved the monitor logs and found no anomalies.The fse also carried out alarm testing, but everything was working correctly.It was requested that the customer provide a specific example of the problem (time, patient, etc.) from the medical staff in order to better analyze it.The customer will contact philips if the problem arises again in order to recover the logs on the control unit.The customer has already requested training for the staff.Based on the information available and the testing conducted, the fse was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The device remains at the customer site.
Additional Manufacturer Narrative
D4: product udi - the manufacturing date for the reported device is prior to 24sept2016.

• 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: 18180661
• Report Number: 9610816-2023-00610
• Device Sequence Number: 18064225
• 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,Followup
• Report Date (Section B): 07/16/2024

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: 11/10/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 07/08/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/20/2023; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2012
• 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