MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEM

Catalog Number MS25707

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 10/02/2016

Event Type  Death  

Manufacturer Narrative

The logs from the bedside m300 and infinity central station (ics) were reviewed.Correspondence regarding the incident and ecg strip reports from the patient surrounding the date and time of occurrence was received for evaluation.Analysis of the m300 logs indicates that between 6:02am and 6:18am on (b)(6), the m300 bedside monitor alarmed several times for life threatening alarms for vtach, vfib.Additional alarms in the m300 logs included aivr arrhythmia, hr less than 45, and ecg artifact.The logs also indicate the user pressed 'alarm pause' a total of 5 times between 6:03am and 6:21am.Per design, if 'alarm pause' is in progress, alarms are suspended and none of the alarms will be reported at either the ics or the bedside, and the user will see an ¿alarm paused¿ banner and associated running timer on the ics display.As indicated in the ifu, "after you click on alarm paused, all current active alarms clear and additional alarm events are suppressed for a predefined time.During the alarm paused time period, the banner alarm paused and time remaining for the pause displays." the ics and associated beside were found to have functioned as designed.

Event Description

It was reported that a patient monitored by an m300 experienced an episode of vfib lasting several minutes, but the associated ics reportedly did not alarm audibly or visually for the vfib event.It was further reported that the patient coded in the event and passed away in the morning of next day.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• Manufacturer Contact: hua felix peng ; 6 tech drive; andover, MA 01810-2434
• MDR Report Key: 6034689
• MDR Text Key: 57680630
• Report Number: 1220063-2016-00038
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MS25707
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• 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