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

Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 08/27/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

A complaint was received regarding an event where the involved patient died.According to the user there was no alarm of the m300.According to the doctor, the deterioration of the patient started at 7:16 pm and at about 8 pm the patient was resuscitated, after which he passed away.Since the m300 did not give an alarm, the resuscitation was started too late.

Manufacturer Narrative

It was noted that the cited m300 was used on another patient after this event, ecg signal issues were noted and the m300 was replaced to resolve the issues.The ics logs were reviewed and the poor ecg signal issue was confirmed by multiple ecg artifact alarm entries seen throughout the event.Note that the criteria for asystole may not be met if an artifact condition is not resolved as artifact can be interpreted as a beat.The device was working as designed in response to the ecg artifact condition by providing the alarms.The cited m300 was returned to draeger and upon inspection, it was noted that the ecg leads connector/contacts were visibly dirty/contaminated.The poor ecg signal/ecg artifact issue was verified during testing using a patient simulator.Cleaning the ecg leads connector/contacts resolved the issue.Therefore, root cause was determined to be a lack of maintenance/cleaning of the device and our device can be excluded as a factor in the patient outcome.The device was system tested and returned to the customer.This is an isolated case.The m300 instructions for use (ifu) indicates that the ecg artifact alarm is provided to alert the user to a technical issue that may compromise the ability of the system to monitor the patient and instructs the users to clean the ecg leads connector with soap, water and a soft-bristled paint brush if there is any visible dirt.

Event Description

A complaint was received regarding an event where the involved patient died.According to the user there was no alarm of the m300.According to the doctor, the deterioration of the patient started at 7:16 pm and at about 8 pm the patient was resuscitated, after which he passed away.Since the m300 did not give an alarm, the resuscitation was started too late.

• 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: 10487931
• MDR Text Key: 205492971
• Report Number: 1220063-2020-00007
• 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
• Report Date: 10/20/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death