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

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the advanced arrhythmia settings for tach/brady/pause went back to the factory default setting of off/off/off after being set to high/low/high by the staff.No adverse patient impact was reported.

Manufacturer Narrative

Screenshots were provided showing the infinity central station (ics) configuration and alarm settings.The ics logs confirm the alarm settings changes were made but not how.The involved m300 logs were requested but as the device remained in use, the logs for the time of the reported issue had been overwritten.In order to determine root cause, both the involved m300 and ics logs need to be collected when the issue occurs.Therefore, root cause can not be determined.Instructions for gathering the information needed if the issue occurs again were provided.The involved m300 and ics remain in use with no further issues reported.This is an isolated case.

Event Description

It was reported that the advanced arrhythmia settings for tach/brady/pause went back to the factory default setting of off/off/off after being set to high/low/high by the staff.No adverse patient impact was reported.

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 8945597
• MDR Text Key: 186752002
• Report Number: 1220063-2019-00017
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1