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

Model Number	MS25755
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/02/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that a patient went into asystole while the infinity m300 was in standby and the patient passed away.No alarms were issued because the m300 was in standby.Though there was no allegation the device cause or contributed to the patient outcome, this case represents a use error of the device during an event where the involved patient died.The device was inadvertently left in standby mode resulting in the device not providing an asystole alarm.The infinity m300 patient worn monitor is used with the infinity central station (ics).Standby mode is used to temporarily interrupt patient monitoring.This may be used when a patient is taking a shower of taken off unit for a procedure/imaging, etc.For the m300, standby mode can only be enabled from the ics.When standby mode is enabled, the user must select the the duration (5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 3 hours).The default setting is 1 hour.Standby mode has the following effect: the standby banner is displayed in the waveform area of the ics main screen, in the bed-view of the patient and in the bed¿s header bars.The standby banner appears at the m300.With the exception of offline alarms, all monitoring (including audible and visual alarm signals) are suppressed at the ics and at the monitor.Active alarms are considered acknowledged.All recordings are canceled.Waveforms continue to display if available at the ics along with the patient name, bed label, parameter labels, and scales.All bedview buttons appear unavailable for selection except for trends/data, admit/standby, main screen, and print screen.You can exit standby mode from the ics or the m300.
Event or Problem Description
It was reported that a patient went into asystole while the infinity m300 was in standby and the patient passed away.No alarms were issued because the m300 was in standby.Though there was no allegation the device cause or contributed to the patient outcome, this case represents a use error of the device during an event where the involved patient died.The device was inadvertently left in standby mode resulting in the device not providing an asystole alarm.The infinity m300 patient worn monitor is used with the infinity central station (ics).Standby mode is used to temporarily interrupt patient monitoring.This may be used when a patient is taking a shower of taken off unit for a procedure/imaging, etc.For the m300, standby mode can only be enabled from the ics.When standby mode is enabled, the user must select the duration (5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 3 hours).The default setting is 1 hour.Standby mode has the following effect: the standby banner is displayed in the waveform area of the ics main screen, in the bed-view of the patient and in the bed¿s header bars.The standby banner appears at the m300.With the exception of offline alarms, all monitoring (including audible and visual alarm signals) are suppressed at the ics and at the monitor.Active alarms are considered acknowledged.All recordings are canceled.Waveforms continue to display if available at the ics along with the patient name, bed label, parameter labels, and scales.All bedview buttons appear unavailable for selection except for trends/data, admit/standby, main screen, and print screen.You can exit standby mode from the ics or the m300.
Additional Manufacturer Narrative
The product risk management report was reviewed, and no new risks were identified.

• Brand Name: INFINITY M300
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEM
• 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: 16641779
• Report Number: 1220063-2023-00007
• Device Sequence Number: 6097345
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: 04049098048989
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: MS25755
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown