MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem Alarm Not Visible (1022)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Death  

Event Description

The customer reported that the device did not give an alarm between 13:00 and 14:00.They did not see an alarm.The patient passed away.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The service engineer was not able to determine the cause of the reported event as logs were too old.The device was returned to the customer site.

Event Description

The customer reported that the device did not give an alarm between 13:00 and 14:00.They did not see an alarm.The patient passed away.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14676131
• MDR Text Key: 293860999
• Report Number: 1218950-2022-00489
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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