MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC M3155 UPGRADE REL N.01

Model Number 866103

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Arrest (1762)

Event Date 03/21/2021

Event Type  Death  

Manufacturer Narrative

A philips field service engineer went onsite to pull the patient logs for the event.A review of the logs indicate that the leads off event alarmed at the central station and was subsequently silenced within two seconds.Since the leads off alarm was silenced at the central station a reset message was sent through iem.This message indicates that the clinical team at the central had accepted, read, and canceled the alert.There was no malfunction of the philips device.The audit logs prove that the system was operating correctly.The clinical staff at the central station had silenced the leads off alert which is why the alert did not go through iem.The customer was informed about how the alarm system works.No further investigation is warranted.The device remains on site and in use.

Event Description

The customer reported that they did not receive an alert in their intellispace event management (iem) system for a leads off event that led to a patient death on (b)(6) 2021 at 2:42 am.

• Brand Name: M3155 UPGRADE REL N.01
• Type of Device: M3155 UPGRADE REL N.01
• 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: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11723117
• MDR Text Key: 247209948
• Report Number: 1218950-2021-10420
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866103
• Device Catalogue Number: 866103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/30/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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