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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the infinity central station "stopped" on september 1st, 8:3pm.No details on the nature of the "stop" was provided.It was then restarted at 9:53 pm.There was no report of adverse patient impact or patient death.
Additional Manufacturer Narrative
The investigation was started but is not yet concluded.We cannot exclude that the investigation alters the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident.We assume that such an analysis can begin 10 days following issuance of this initial report, unless the national competent authority contacts us within this time frame opposing an analysis which involves altering the device.
Additional Manufacturer Narrative
Multiple attempts for information were made, and no additional information was provided.No root cause or patient impact could be determined.If additional information is made available, the complaint may be reopened.
Event or Problem Description
The customer reported that the infinity central station "stopped" on (b)(6), 8:3pm.No details on the nature of the "stop" was provided.It was then restarted at 9:53 pm.There was no report of adverse patient impact or patient death.

• 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: 20339137
• Report Number: 1220063-2024-00110
• Device Sequence Number: 7945608
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)230601(93)MS26800-13
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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 Model Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown