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

Catalog Number MS25755

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 11/30/2023

Event Type  Death  

Event Description

The following has been reported to draeger: on (b)(6) 2023 at 6 pm (18:00) an arrhythmia alarm of the m300 "tele02" was issued at the infinity central station (ics) the alarm was then relayed by telephone by the icu 32 user at the telemetry station on the 5th floor and the icu 32 user silenced the alarm for 10 minutes.At 7 pm (19:00), the ics control center issued an asystole alarm from the m300 "tele02", which was also relayed to the user on the 5th floor.The resuscitation efforts were unsuccessful.A later check of the ics center data revealed that no ecg and trend data of the patient were stored between the two alarms between 6 pm and 7 pm.

Manufacturer Narrative

The dispatched dreager service engineer has tested both m300 and infinity central station.The devices did not exhibit deviation from specification.Interviews with the user could than clarify that the user has indeed put the m300 into standby after the first alarm at 6 pm for one hour.This explains why the next alarm was raised not before 7 pm and why no data was stored during the period in between.The investigation revealed the reported incident must be attributed to use error.Instead of silencing the alarm the user has but the m300 into standby for one hour with a net effect of the patient not being monitored during this period.The next alarm was then raised as intended after the standby period was over.As a consequence, the user intervention obviously came too late, and the patient died.Standby mode is used to temporarily interrupt patient monitoring.The ifu clearly explains in detail that 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.You can exit standby mode from the ics or the m300.The ifu contains a warning that the patient must be taken out of standby to resume monitoring.

• 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 INFANT CARE, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 18289127
• MDR Text Key: 329992410
• Report Number: 1220063-2023-00047
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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