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

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

Patient Problem Ventricular Tachycardia (2132)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.A follow up report will be sent once the investigation is completed.

Event Description

It was reported that a patient being monitored on an m300 experienced what the nursing staff interpreted as a vtach event with a hr of 180 but the ics displayed a yellow svt alarm instead of the expected red vtach alarm.There was no patient injury reported.

Manufacturer Narrative

The m300 logs, ics setup and m300 patient monitor were requested back for analysis but were not available.The device analysis of the event screen shot shows the heart rate suddenly increased from 76 beats per minute (bpm) to 180 bpm, but the qrs complex shapes showed no change on lead ii or lead v.Since the beats at the time of the event are the same as the normal template built in the relearn phase, all the beats were classified as normal beats, and therefore, an svt alarm was issued (not vtach).This is consistent with normal device behavior based on the ecg arrhythmia algorithm, template, and beat classification.There is no indication of a device malfunction.

Event Description

Please refer to the initial report.

• Brand Name: ICS 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: dhaval trivedi ; 6 tech drive; andover, MA 01810-2434
• MDR Report Key: 6586124
• MDR Text Key: 75919681
• Report Number: 1220063-2017-00032
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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