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

Catalog Number	MS18384
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
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 a patient with a short term total block with symptoms who needed telemetry monitoring could not be monitored due to technical issues and troubleshooting ongoing in the telemetry unity.The specific malfunction of the telemetry was not provided.The patient was temporarily moved out into the corridor.It was confirmed that that the patient does did need to return to hia at the time.The report states that the icu had not been informed of the telemetry malfunctions.No adverse patient impact was reported.
Additional Manufacturer Narrative
A complaint was received where a customer reported that a patient could not be connected to telemetry due to technical issues and troubleshooting ongoing in the telemetry unit.It was also stated that it should be routine to inform responsible clinicians of any technical issues that are occurring with the telemetry system.The patient had to be temporarily moved into the corridor to be assessment and no adverse patient impact was reported.Several attempts were made to clarify the specific nature of the technical issues the customer states was occurring in the telemetry unit, the exact devices that were affected and the event logs for the time of the event however, this information was not made available.Therefore, further investigation into the event is not possible and a root cause cannot be determined.If additional information is provided, the complaint will be reopened.
Event or Problem Description
The customer reported that a patient with a short term total block with symptoms who needed telemetry monitoring could not be monitored due to technical issues and troubleshooting ongoing in the telemetry unity.The specific malfunction of the telemetry was not provided.The patient was temporarily moved out into the corridor.It was confirmed that that the patient does did need to return to hia at the time.The report states that the icu had not been informed of the telemetry malfunctions.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: 19632383
• Report Number: 1220063-2024-00071
• Device Sequence Number: 7093467
• Product Code: MHX
• UDI-Device Identifier: 04049098050449
• UDI-Public: (01)04049098050449(11)150130(93)MS18384-16
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• 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): 10/22/2024

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: MS18384
• 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: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2015
• 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