MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX750

Model Number 866471

Device Problem No Audible Alarm (1019)

Patient Problems Apnea (1720); Insufficient Information (4580)

Event Date 11/30/2022

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

The customer reported that the patient had a desat event.User noticed visual alarm banners displayed on the monitor.However; they did not hear audible alarm tones.Patient care had to be escalated.The patient expired later during the day.Customer needs assistance with explaining alarm processing.

Event Description

This report is based on information provided by philips field service and product support engineering personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the intellivue mx750 patient monitor indicating the device did not provide an audible alarm for a desat and apnea event.The event resulted in a patient death.Visual inspection found no device issues.A philips field service engineer (fse) went to the customer site.The pse obtained the event logs and configuration file.A philips product support engineer (pse) reviewed the logs and configuration file.The pse concluded the bedside device alarmed as expected.However, per the customer, profile msicu/nticu was used during the event.This monitor settings block has an alarm low volume of two and an alarm volume of three, both of which are quite low.Depending on the environment an audible alarm at these volumes might be extremely hard to notice.Results of functional testing indicate the device alarmed as expected during the event, but the volume of the alarm may have been too low for the customer to hear based on the device configuration.The device was confirmed to be operating per specifications and no failure was identified.Per good faith effort response, the patient outcome was due to a traumatic brain injury.Philips device did not contribute to the patient outcome.

• Brand Name: INTELLIVUE PATIENT MONITOR MX750
• Type of Device: INTELLIVUE PATIENT MONITOR MX750
• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16067179
• MDR Text Key: 306322228
• Report Number: 9610816-2022-00660
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866471
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 02/21/2023
• Date Device Manufactured: 07/21/2021
• 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
• Patient Outcome(s): Death
• Patient Sex: Female