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

Model Number	N/A
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The medical technician reported to the fse that an error occurred on 09/27/2024.The complaint reports that there were missing curves on the standalone iacs, and that the malfunction would reoccur.It was reported that the information can't be seen on the central, and there is no alarm heard or seen.There is reportedly no alarm of the disconnection.There was no report of adverse patient impact or death.
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
The medical technician reported to the fse that an error occurred on 09/27/2024.The complaint reports that there were missing curves on the standalone iacs, and that the malfunction would reoccur.It was reported that the information can't be seen on the central, and there is no alarm heard or seen.There is reportedly no alarm of the disconnection.There was no report of adverse patient impact or death.
Additional Manufacturer Narrative
The logs were reviewed by draeger, the reported disconnects were confirmed.The m500 docking station was found to have the incorrect firmware (fw) version at 4.2.The field service technician (fse) upgraded the firmware to fw5.0.On the m500.The disconnect issue then reoccurred in october.When the fse attempted to retrieve the logs there was an error, and the logs could not be retrieved.As no further logs were available for review, the root cause of the reoccurrence could not be determined.The customer downgraded to vg7.1.1, and the fse stated that he would follow up with the customer to see if this issue continued.As of december, there have been no further issues reported.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784097390
• MDR Report Key: 20407110
• Report Number: 1220063-2024-00117
• Device Sequence Number: 15018206
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)120410(93)MS20401-10
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Catalogue Number: MK32500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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