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

Catalog Number MS20401

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Sense (1559); Inappropriate or Unexpected Reset (2959); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that: on (b)(6) 2021, while the patient was being resuscitated, the m540 (4.1) rebooted 3 times (13h16:56 to 13h17:13, 13h18:59 to 13h19:12, 13h34:46 to 13h37:10).A rev 17 co2 cable ((b)(4)) was connected to the m540.After the 3rd reboot, the m540 went back to default setting (including views) but patient remained admitted at the central station.The involved patient died.

Manufacturer Narrative

Communication with the site verified that the rebooting of the m540 did not contribute to the patient event or resulting patient death.Root cause was identified as a software issue where the m540 reboots in response to receiving low accuracy messages from the etco2 pod.This issue was address via fsca tsb 15 and corrected in vg4.1.1.The site also verified that updating the device software resolved the issue of the m540 rebooting.A device reboot or shutdown is visibly obvious to the user and an audible tone is provided to alert the user.Patient monitoring is restored automatically after the reboot.In the event 3 reboots occur in under 10 minutes, the device goes into a "fail state" and a constant alarm tone is provided.A message is displayed at the associated cockpit and infinity central station (ics) indicating the m540 is disconnected/offline.

Event Description

It was reported that: on (b)(6) 2021, while the patient was being resuscitated, the m540 (4.1) rebooted 3 times (13h16:56 to 13h17:13, 13h18:59 to 13h19:12, 13h34:46 to 13h37:10).A rev 17 co2 cable (ref (b)(4)) was connected to the m540.After the 3rd reboot, the m540 went back to default setting (including views) but patient remained admitted at the central station.The involved patient died.

• 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
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 11501004
• MDR Text Key: 240346471
• Report Number: 1220063-2021-00011
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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
• Treatment: NA.; NA.
• Patient Outcome(s): Death