MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number MS25755

Device Problems Defective Alarm (1014); No Audible Prompt/Feedback (2282); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/19/2021

Event Type  Death  

Manufacturer Narrative

Initial assessment of the information provided shows the log files don¿t include any data from that date of the event as they start on the 21st.From the screen captures provided from the event, a loss of ecg waveforms for leads i and v and an ecg leads off alarm message is shown at 16:35:31.As the arrhythmia processing leads (lead i and v) were disconnected, no arrhythmia monitoring was occurring.The clinician would have been notified of the leads off condition by the alarm provided as well as by no heart rate or waveforms being displayed.A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that: we have received a report that an m300 failed to alarm with the ics when a patient suffered a cardiac arrest.Unfortunately when found it was too late to resuscitate.Patient was in a side room being monitored on the m300.The patient had a cardiac arrest on 20:14 it shows on one of the screenshots.It was only displaying lead iii at that time.Lead iii had a vf but it did not alarm at all.When patient was found it was too late and resuscitation efforts failed.There is no wireless network interruption and parameters reached the ics ok before during and after the incident.

Manufacturer Narrative

A draeger technician evaluated the involved infinity central station (ics) and m300 with no malfunctions identified.From the ecg full disclosure screenshots provided, it was verified that only a lead iii signal was displayed at the time of the event.An ecg leads off alarm was provided to alert the user of the leads off condition.As the arrhythmia processing was set on leads i and v, and these were not connected, no arrhythmia monitoring was occurring.The clinician would have been notified of the leads off condition by the alarm provided as well as by no heart rate or waveforms being displayed.There was no device malfunction.Note that the cited m300 provides users with the option to set leads off alarms to low (default), medium or high priority.In this case, the alarm was set to low priority.The customer was provided the results of this investigation and training materials relating to leads off behavior.

Event Description

It was reported that: we have received a report that an m300 failed to alarm with the ics when a patient suffered a cardiac arrest.Unfortunately when found it was too late to resuscitate.Patient was in a side room being monitored on the m300.The patient had a cardiac arrest on 20:14 it shows on one of the screenshots.It was only displaying lead iii at that time.Lead iii had a vf but it did not alarm at all.When patient was found it was too late and resuscitation efforts failed.There is no wireless network interruption and parameters reached the ics ok before during and after the incident.

Manufacturer Narrative

A draeger technician evaluated the involved infinity central station (ics) and m300 with no malfunctions identified.From the ecg full disclosure screenshots provided, it was verified that only a lead iii signal was displayed at the time of the event.An ecg leads off alarm was provided to alert the user of the leads off condition.As the arrhythmia processing was set on leads i and v, and these were not connected, no arrhythmia monitoring was occurring.The clinician would have been notified of the leads off condition by the alarm provided as well as by no heart rate or waveforms being displayed.There was no device malfunction.Note that the cited m300 provides users with the option to set leads off alarms to low (default), medium or high priority.In this case, the alarm was set to low priority.The customer was provided the results of this investigation and training materials relating to leads off behavior.

Event Description

It was reported that: we have received a report that an m300 failed to alarm with the ics when a patient suffered a cardiac arrest.Unfortunately when found it was too late to resuscitate.Patient was in a side room being monitored on the m300.The patient had a cardiac arrest on 20:14 it shows on one of the screenshots.It was only displaying lead iii at that time.Lead iii had a vf but it did not alarm at all.When patient was found it was too late and resuscitation efforts failed.There is no wireless network interruption and parameters reached the ics ok before during and after the incident.

• Brand Name: INFINITY M300
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 11398555
• MDR Text Key: 234244201
• Report Number: 1220063-2021-00010
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K151860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/23/2021; 02/23/2021
• Supplement Dates FDA Received: 04/23/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death