MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number MS26372

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 01/28/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that: infinity m540s with nellcor spo2 are used for patient monitoring on ward a0 in the clinic.After a patient died, it was found that the spo2 alarm configuration parameter "check spo2 sensor" was set to off and therefore no alarm was triggered.In contrast to the station configuration in which the alarm is set to "medium", the alarm has been deactivated in this case.The customer now requests to be able to lock this function with a password so that the sensor behavior can no longer be changed by the user.

Manufacturer Narrative

The customer requested to know when the "spo2 check sensor" alarm was disabled.Additional information was provided clarifying the time of the event as (b)(6) 20:30.After review of the ics logs, it was found they only went back to (b)(6).As a result, nothing could be determined from the ics logs.After review of the m540 log files, it was found the earliest entry dated back to (b)(6) at 13:04.The oldest entry where the "spo2 check sensor" alarm grade was changed was at 11:33 on (b)(6) where the alarm was changed back to high.Since this is the oldest entry and the logs only go back to (b)(6) at 13:04, it could be determined the "spo2 check sensor" alarm grade was changed to off prior to (b)(6) at 13:04.A precise time could not be determined however as this time was overwritten.It could also be determined that the spo2 limit alarm was set to off on (b)(6) at 6:01 and was not enabled again until after the event at (b)(6)at 11:39.There was no device malfunction.The vg4.N m540 instructions for use identifies password protected alarm settings.A product enhancement request has been opened to consider password protecting the "spo2 check sensor" (nellcor) and "spo2 sensor off" (masimo) alarms.This is an isolated complaint.

Event Description

It was reported that: infinity m540s with nellcor spo2 are used for patient monitoring on ward a0 in the clinic.After a patient died, it was found that the spo2 alarm configuration parameter "check spo2 sensor" was set to off and therefore no alarm was triggered.In contrast to the station configuration in which the alarm is set to "medium", the alarm has been deactivated in this case.The customer now requests to be able to lock this function with a password so that the sensor behavior can no longer be changed by the user.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 11332616
• MDR Text Key: 231985706
• Report Number: 1220063-2021-00005
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS26372
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death