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

Model Number MS20401

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  Death  

Event Description

It was reported by the site biomedical engineer that there was an ecg leads off condition for approximately 45 minutes and the m540 monitor did not alarm and the involved patient died.At this time the exact date of the event was unknown, only that it was 2-3 weeks prior to (b)(6) 2021.[date of death estimated as (b)(6) 2021] the site biomed stated they were not notified when the event occurred, the monitor was not taken out of use and the event was not locked at the infinity central station (ics) ics.Therefore, the event logs from the m540 and the ics may have been overwritten.The involved device and others were checked out and it was confirmed that they function properly and alarmed for the ecg leads off situation.It was noted that the ecg leads off alarm priority was set at low (default) and the alarm volume setting was 20%.Additionally, it was noted that the ics is not monitored 100% of the time and that staff may have selected ¿privacy mode¿ on the bedside monitor.

Manufacturer Narrative

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

Manufacturer Narrative

As previously stated, the site biomed tested the device and confirmed that the device was properly alarming for an ecg leads off condition at the time of testing.It was found that the leads off alarm was configured as a low priority alarm and the device alarm volume was set to 20%.After the event, the site has updated their device settings to make alarms more easily identifiable.After further communication with the site, it was also determined that the ics is not monitored at all times and it was possible that "privacy mode" had been turned on, both of which could prevent alarms from being noticed by the user.Additionally, it was noted that the patient was also connected to a ventilator during the event.The ventilator mask had either fallen off or was pulled off by the patient and the staff indicated that the ventilator also did not alarm.The ventilator logs were reviewed and it was confirmed that the ventilator did issue alarms.The date of the event was clarified as on (b)(6) 2021.The involved m540 and ics log files provided were reviewed by draeger engineering.It was determined that the log files from the date of the reported event were overwritten and therefore could not aid in this investigation.A draeger technician evaluated the device with no malfunctions identified.Therefore, we are unable to verify the reported failure to alarm and root cause cannot be definitively determined.H3 other text: a draeger technician evaluated the device with no malfunctions identified.

Event Description

It was reported by the site biomedical engineer that there was an ecg leads off condition for approximately 45 minutes and the m540 monitor did not alarm and the involved patient died.At this time the exact date of the event was unknown, only that it was 2-3 weeks prior to on (b)(6).[date of death estimated as on (b)(6) 2021].The site biomed stated they were not notified when the event occurred, the monitor was not taken out of use and the event was not locked at the infinity central station (ics) ics.Therefore, the event logs from the m540 and the ics may have been overwritten.The involved device and others were checked out and it was confirmed that they function properly and alarmed for the ecg leads off situation.It was noted that the ecg leads off alarm priority was set at low (default) and the alarm volume setting was 20%.Additionally, it was noted that the ics is not monitored 100% of the time and that staff may have selected ¿privacy mode¿ on the bedside monitor.

Event Description

It was reported by the site biomedical engineer that there was an ecg leads off condition for approximately 45 minutes and the m540 monitor did not alarm and the involved patient died.At this time the exact date of the event was unknown, only that it was 2-3 weeks prior to (b)(6) 2023.[date of death estimated as (b)(6) 2021].The site biomed stated they were not notified when the event occurred, the monitor was not taken out of use and the event was not locked at the infinity central station (ics) ics.Therefore, the event logs from the m540 and the ics may have been overwritten.The involved device and others were checked out and it was confirmed that they function properly and alarmed for the ecg leads off situation.It was noted that the ecg leads off alarm priority was set at low (default) and the alarm volume setting was 20%.Additionally, it was noted that the ics is not monitored 100% of the time and that staff may have selected ¿privacy mode¿ on the bedside monitor.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.H3 other text : a draeger technician evaluated the device with no malfunctions identified.

• 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
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 13121334
• MDR Text Key: 282994262
• Report Number: 1220063-2021-00035
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: 04049098054454
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MS20401
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/26/2022; 01/26/2022
• Supplement Dates FDA Received: 02/20/2022; 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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