MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

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.Reporting institution phone (b)(6).Reporter phone (b)(6).

Event Description

Philips received a complaint on the intellivue mx450 patient monitor indicating speaker malfunction.It was unknown if the device produced audible sound.The device was in use on patient at time of event, there was no adverse event reported.

Event Description

It was reported the x3 had a speaker malfunction.The customer later on confirmed the speaker inoperative alarms originated from the x3 speaker and not the mx450 monitor.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

A philips remote service engineer (rse) remotely interviewed the customer.The customer felt they were getting a lot of alarms they did not understand the reasoning behind them.The rse checked through their logs and confirmed this was in fact true, but the logs did not show a clear explanation as to why.The customer later on confirmed the speaker inoperative alarms originated from the x3 speaker.The x3 had audible sound even though there was a speaker inoperative message present.The mx450 sound worked fine as did the x3 sound.Such issues tend to occur when the x3 operates in companion mode, for long periods of time, with a host monitor.Based on the information provided in the case and by the philips rse, the cause of the reported problem was confirmed to be the x3 when connected in companion mode to a host monitor for a long periods of time.The customer still experienced inoperative alarm messages, and they will take responsibility for the ongoing investigations by observing these alarms when they happen.They will also take notice of how the unit is being used at that time by the hospital staff.The customer and the clinical specialist have met and did not hear anything more regarding this issue.No further investigation or action is warranted at this time.It was confirmed that sound was still coming from the x3 and the inop with confirmed sound is not reportable.The speaker malfunction inop seemed to be related to an issue the x3 has when connected in companion mode for a longer periods of time to a host monitor.A good faith effort confirmed a device update from the intellivue mx450 patient monitor, 866062, sn (b)(6) to the intellivue x3, 867030, sn unknown.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 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 ; 7031463203
• MDR Report Key: 18900382
• MDR Text Key: 337668808
• Report Number: 9610816-2024-00144
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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 Operator: Health Professional
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/14/2024
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1