MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS25520
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported that the bedside monitor performs sporadic reboots and does not connect itself to the cockpit again afterwards, visualization of vital parameter is thus impaired.The issue occurs when hf surgery equipment is being used but not each time.For remedy, a new bedside monitor must be introduced.No patient consequences have occurred.
Additional Manufacturer Narrative
It was reported that the patient monitor reboots intermittently when a rf surgery device is being used while the hfc signal filter is enabled at the monitor.The device does not automatically connect to the cockpit again and, the users had to introduce a new patient monitor which successfully connected to the cockpit.Information alleging a defect of the hf device was provided, but no information regarding the defect was provided.The user facility purchased new grounding mats for the hf devices, and the issue has not reoccurred since.The provided logs were analyzed, and no m540 reboot could be confirmed for the reported events.With the provided information, no specific defect could be determined.No further issues have been reported.H3 other text : see h10.
Event or Problem Description
It was reported that the bedside monitor performs sporadic reboots and does not connect itself to the cockpit again afterwards, visualization of vital parameter is thus impaired.The issue occurs when hf surgery equipment is being used but not each time.For remedy, a new bedside monitor must be introduced.No patient consequences have occurred.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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 ; 9783798000
• MDR Report Key: 18118941
• Report Number: 9611500-2023-00405
• Device Sequence Number: 20551620
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)201112(93)MS25520-63
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• 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): 04/24/2024

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: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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: NA.; NA.
• Patient Sex: Unknown