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

Catalog Number	MS18501
Medical Device Problem Codes	No Device Output (1435); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was no alarm at the ics when an ecg or spo2 cable is disconnected from the m300.The user at the central will potentially will not know that the patient is no longer being monitored which has the potential for adverse patient impact.No injury or other patient impact was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
It was reported to draeger that when the m300 cable disconnected there was no alarm.The available ics logs and a movie of the event occurring were analyzed by draeger engineering.The movie and the ics logs do confirm alarming for the cited bed (tele 1) but no alarms were generated during the reported date of event (3-15-2024 @ 15:21) for this m300 device.The m300 alarm logs are necessary to further investigate the cause of the issue.Unfortunately the logs were unavailable for this investigation.Based on the evidence provided to investigate this issue, a root cause could not be determined for the reported behavior.
Event or Problem Description
The customer reported that there was no alarm at the ics when an ecg or spo2 cable is disconnected from the m300.The user at the central will potentially will not know that the patient is no longer being monitored which has the potential for adverse patient impact.No injury or other patient impact was reported.

• Brand Name: M300
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 19037547
• Report Number: 1220063-2024-00038
• Device Sequence Number: 15484017
• Product Code: MHX
• UDI-Device Identifier: 04049098004183
• UDI-Public: (01)04049098004183(11)161118(93)MS18501-35
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: MS18501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown