MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number	MS26800
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the m300+ made a beep, rebooted a few times and then the patient was discharged on the central.The customer changed the battery, and are keeping the device in use.No report of customer injury or death was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : device not returned for evaluation.
Additional Manufacturer Narrative
It was reported to draeger that the ics lost the signal from the m300 and discharged the patient.The ics logs provided were analyzed by draeger engineering and were found to be inconclusive considering the reported problem is reportedly with the m300.Without the m300 logs and additional information necessary to determine a root cause into the reported issue it is not fully understood why this issue occurred and we cannot confirm or deny what was reported to us.Several requests were made for the m300 logs along with the necessary information to conduct a complete investigation.Despite our best efforts, the customer would not allow access to the m300 and further information.This complaint is being closed and if in the future the m300 logs and the information become available a new complaint will be opened to investigate these new materials.
Event or Problem Description
The customer reported that the m300 plus made a beep, rebooted a few times and then the patient was discharged on the central.The customer changed the battery and are keeping the device in use.No report of patient injury or death was reported.

• Brand Name: INFINITY CENTRAL STATION
• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 19340974
• Report Number: 1220063-2024-00058
• Device Sequence Number: 8693399
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)190320(93)MS26800-36
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: MS26800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2019
• 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: N/A.; N/A.
• Patient Sex: Unknown