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

Model Number	MS25755
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that an incident occurred where is was alleged that the infinity central station (ics) did not provide an alarm.Manual cpr was provided however, the involved patient died.The draeger infinity m300 patient worn monitor is used with the infinity central station (ics).The m300 provides alarms to the ics.(involved m300 serial number (b)(4) and associated ics serial number (b)(4).
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Additional Manufacturer Narrative
Review of the m300 logs showed six asystole alarms starting at 11:36 and 11:41.The ics logs show the audio pause for bed-32 being initiated to address the m300 asystole alarms (11:37-11:40 and 11:41-11:43).The complainant confirmed the m300 and ics were both functioning correctly after testing was performed by a draeger technician when the incident was reported.There is no information to support a malfunction of the draeger device occurred.
Event or Problem Description
It was reported that an incident occurred where is was alleged that the infinity central station (ics) did not provide an alarm.Manual cpr was provided however, the involved patient died.The draeger infinity m300 patient worn monitor is used with the infinity central station (ics).The m300 provides alarms to the ics.(involved m300 serial number: (b)(6) and associated ics serial number: (b)(6).

• Brand Name: INFINITY M300
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 15153540
• Report Number: 1220063-2022-00011
• Device Sequence Number: 20234425
• 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): 10/26/2022

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): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female