MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3155 UPGRADE REL N.0; CENTRAL STATION MONITOR

Model Number M3155

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/07/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that a patient death occurred on (b)(6) between 3:10 pm and 3:30 pm.The customer requested assistance in determining if alarms had occurred and if they were silenced.A patient death occurred.

Manufacturer Narrative

The customer called the customer care solutions center for troubleshooting support.The customer stated that they thought alarms may have been paused or silenced but wanted to determine this with assurance.The customer retrieved log files and submitted them for review.For the timeframe of 3:10 to 330 pm it was noted that the patient had vtach, vfib/tach and tachy alarms which were silenced at the central monitor with additional similar alarms persisting until 15:52 when the alarms were paused/suspended.A review of the provided log file data was shared with the customer who had suspected this was a use issue.The device remains in use.No malfunction is supported.The customer requested information regarding what alarms occurred and if the alarms were responded to surrounding the death of a patient on (b)(6).The customer provided log data which demonstrated multiple red level alarms occurring with silencing actions taken by users at the information center.A local fse went on site and found the product operating as intended.No malfunction is supported.

• Brand Name: M3155 UPGRADE REL N.0
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7125214
• MDR Text Key: 95159003
• Report Number: 1218950-2017-08489
• 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,Followup
• Report Date: 12/08/2017

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: M3155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• 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 Age: 80 YR