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

Catalog Number MS33648

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problem Tachycardia (2095)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient had a run of bqrs complex tachy 150bpm, the m300 didn't alarm, only showed medium alarm for hr greater than 135 bpm.The issue occurred on (b)(6) at 00:11am.No adverse patient impact was reported.Note that the draeger infinity m300+ does not have a 510k number as is not registered in the usa.The m300+ is similar to the draeger infinity m300.Therefore, this report is being submitted under the 510k for the m300.

Manufacturer Narrative

Review of the infinity centralstation (ics) logfile showed that during the time of event, on the 17th of february 2023 the ics provided a medium priority svt alarm for the involved bedside at 00:11:24 and multiple medium priority hr > 135 alarms.There were no entries for vtach alarms during the event, as reported by the user.A 20 second ecg print strip from lead iii on 17feb at 00:11:23, a screenshot of the bedview from the ics which shows an ¿arr cannot learn lead iii¿ message displayed on 17feb at 00:14 (approx.3 minutes after the time of the ecg strip provided) and a screenshot of the alarm limit settings were provided.Though the ¿arr cannot learn lead iii¿ message indicates that lead iii was selected as an arrhythmia (arr) monitoring lead during the event, without knowing if the dual or single channel option was selected and if dual, the second lead selected, as well as ecg strips from the second lead at the time of the event, we cannot determine why the expected vtach alarm was not provided.Additional information was requested including arrythmia monitoring settings during the event and all full disclosure ecg strips from the event but this information was not available.Therefore, root cause cannot be determined.From the ics/m300/m300+ instructions for use: appropriate lead selection is essential for accurate arrhythmia monitoring.It is ideal to assign the two best ecg leads as the arrhythmia monitoring leads.The following two options are available: ¿ ecg 1 (single channel option) ¿ dedicates processing to the lead selected as the top waveform displayed.¿ ecg 1 & 2 (dual channel option) ¿ determines the heart rate and arrhythmia based on the leads selected as top two waveforms.Per instruction for use for the ics and m300: the cause for the arrythmia message "arr cannot learn (arrhythmia lead)" is after 100 beats, the m300 cannot determine the dominant normal complex on any lead selected for qrs processing.The remedy per instruction for use is to a) check the electrode preparation or b) reapply electrodes if necessary.H3 other text : see h10.

Event Description

It was reported that a patient had a run of bqrs complex tachy 150bpm, the m300+ didn't alarm, only showed medium alarm for hr greater than 135 bpm.The issue occurred on 17th of feb at 00:11am.No adverse patient impact was reported.Note that the draeger infinity m300+ does not have a 510k number as is not registered in the usa.The m300+ is similar to the draeger infinity m300.Therefore, this report is being submitted under the 510k for the m300.

• Brand Name: INFINITY M300+
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA
• MDR Report Key: 16668306
• MDR Text Key: 312720253
• Report Number: 1220063-2023-00005
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K200859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS33648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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