MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MMX

Model Number 867036

Device Problem No Audible Alarm (1019)

Patient Problems Brain Injury (2219); 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.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.Pse got the event logs and configuration file.A philips product support engineer (pse) reviewed the logs and configuration file.The pse concluded that the device alarm happened as expected.However, according to the customer, the msicu/nticu profile was used during the event.This block of monitor settings has a low alarm 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 can be extremely difficult to hear.By good faith effort response, the patient's death was due to a traumatic brain injury and not related to any philips device.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.

• Brand Name: INTELLIVUE MMX
• Type of Device: INTELLIVUE MMX
• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 16076596
• MDR Text Key: 306403821
• Report Number: 9610816-2022-00664
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181831
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 867036
• Device Catalogue Number: 867036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2021
• 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