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

Medical Device Problem Codes	Insufficient Device Problem Information (3190); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the m300+ lost connection to the wireless network while the device was in use with a patient.There was no adverse patient impact and no report of injury at the time of the event.
Event or Problem Description
It was reported that the m300+ lost connection to the wireless network while the device was in use with a patient.There was no adverse patient impact and no report of injury at the time of the event.
Additional Manufacturer Narrative
Additional information provided by the customer confirmed the m300 was offline for approximately 25 minutes.It was noted that a third-party contractor performed a site survey in 2023 prior to installation of the equipment and connecting m300s to the wireless network access points and draeger verified this site survey at the time.Following this event, the customer contacted draeger regarding this concern and it was confirmed that the issue was with the wireless network connectivity and not a malfunction of the m300.The field service engineer at the hospital planned to install software updates on the infinity centralstation (ics) and m300s as well as ensure proper functioning of the wireless network at the hospital.The hospital utilized a third-party wireless infrastructure and worked with a third-party company to check the network.Both the network and equipment were updated.Following extensive testing, the hospital network was found to work with the m300s without interruption and the issue was confirmed to have been resolved.In conclusion, although the m300+ went offline during use, the device operated as intended, and the network connection issue was identified to be related to the hospital network and not the device itself.The instructions for use inform the user that the ics is to be used as the primary monitor for all m300 devices; however, if the m300+ loses connection to the network, the device continues to monitor the patient, all alarms at the local device will go to 100% volume level, and a message will appear at the ics to alert the clinician of the offline condition.

• Brand Name: INFINITY M300+
• Common Device Name: 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784097390
• MDR Report Key: 20591824
• Report Number: 1220063-2024-00128
• Device Sequence Number: 12401675
• Product Code: MHX
• UDI-Device Identifier: 04049098004183
• UDI-Public: (01)04049098004183(11)220707(93)MS33648-07
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown