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

Catalog Number	MS25510
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that on april 1st around 9:45am that the iacs rebooted twice during electrosurgery, and that it was "not clear if the m540 continued to monitor the patient".No patient injury or death was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
It was reported by the customer that on april 1st around 9:45am that the iacs rebooted twice during electrosurgery, and that it was "not clear if the m540 continued to monitor the patient".No patient injury or death was reported.It was confirmed, the m500 in question was running firmware revision 4.2.Draeger service had recommended as of july 2024 that the firmware be upgraded to 4.4, and then to see if that resolved the issue.Draeger service had also asked for a picture of the draeger label on the m500 to determine if the hardware is an older revision.After multiple follow up attempts, the customer has not responded with the requested picture nor has requested a service dispatch to upgrade the m500s firmware therefore as of october 2024, service for the device has not been conducted.Based on the information available a root cause could not be determined.The device remains in use at the customer site.If more information should become available, a child record associated with this complaint will be opened for proper documentation.
Event or Problem Description
It was reported by the customer that on april 1st around 9:45am that the iacs rebooted twice during electrosurgery, and that it was "not clear if the m540 continued to monitor the patient".No patient injury or death was reported.

• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 19184909
• Report Number: 1220063-2024-00049
• Device Sequence Number: 7412487
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)200318(93)MS25510-63
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: MS25510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown