MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX850 PATIENT MONITOR

Model Number	866470
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported no audible sound during vf alarm from the device.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).
Additional Manufacturer Narrative
Upon further investigation it was found that the event is not a reportable event for philips.Objective evidence was provided by the customer that there was no malfunction - the event is therefore not-reportable.If the customer reports alarms are self-silencing, or alarms stop ringing and there is supporting data that the event occurred due to configured/expected alarm reminder behavior then the issue does not represent a malfunction; this is not reportable.Reminders occur only after the alarm has been presented once to the user and a user has invoked the "silence" button.Product labeling describes alarm reminder behavior.

• Brand Name: INTELLIVUE MX850 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX850 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: 16688420
• Report Number: 9610816-2023-00154
• Device Sequence Number: 6080145
• Product Code: MHX
• UDI-Device Identifier: 00884838070790
• UDI-Public: 00884838070790
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K210906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 866470
• Device Catalogue Number: 866470
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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