MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. M300; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS26076
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the m300 transmission to the ics was sporadically disrupted.Details regarding the length and frequency of the disruptions was not provided.There was no report of patient injury or death.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that the m300 transmission to the ics was sporadically disrupted.Details regarding the length and frequency of the disruptions was not provided.There was no report of patient injury or death.
Additional Manufacturer Narrative
It was reported to draeger that the m300 "sporadically" lost connection with the control center.There was no adverse patient impact reported, and the reported complaint stated that there was no patient involvement, and that alarms were generated.The device logs were not provided for analysis and the device remains in the customer's possession.It was confirmed that a "network health check" had been conducted at the hospital, and that the hospital infrastructure was found to be insufficient.To resolve the issue, the hospital added access points and optimized the network configuration.No further issues have been reported.Draeger confirmed the issue was caused by the customer's network infrastructure and the m300 performed as intended with no malfunction.

• Brand Name: M300
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 19355075
• Report Number: 1220063-2024-00059
• Device Sequence Number: 7619011
• Product Code: MHX
• UDI-Device Identifier: 04049098002035
• UDI-Public: (01)04049098002035(11)220929(93)MS26076-34
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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
• Device Catalogue Number: MS26076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown