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

Catalog Number	UNKNOWN
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the patient monitor goes out and it marked as offline at the central, and that the patient data is no saved.The customer also reported that the patient information appeared at the central station 4 hours after the patient was connected to the telemetry unit at 2 am.The staff stated that the patient information had not been observed at the central station until 6 am.No adverse patient impact was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The customer reported a screen goes out, marked as offline at the centrals station and patient data is not saved.The staff also stated that patient information had not been observed at the central station until 6 am and ecgt was registered by events did not seem to be saved.No adverse patient impact was reported.Several attempts were made to determine the exact telemetry device in use (m540, m300), if the offline message was also seen and/or monitoring continued with the bedside monitor, if logs of the date of event were available for analysis and what the resolution was to the stated issue however, according to the 07nov24 email response, this information was not available.Due to the lack of information a root cause of the stated complaint is not known at this time.If more information should become available, a child record associated with this complaint will be opened for proper documentation.
Event or Problem Description
The customer reported that the patient monitor goes out and it marked as offline at the central, and that the patient data is not saved.The customer also reported that the patient information appeared at the central station 4 hours after the patient was connected to the telemetry unit at 2 am.The staff stated that the patient information had not been observed at the central station until 6 am.No adverse patient impact was reported.

• Brand Name: INFINITY CENTRAL STATION
• 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 ; 9784828529
• MDR Report Key: 19632392
• Report Number: 1220063-2024-00073
• Device Sequence Number: 7065447
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)221018(93)MK32700-04
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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