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

Model Number	N/A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started.A follow up report will be submitted upon completion.
Event or Problem Description
It was reported that the st change in vector magnitude (stcvm) was visible and trends were registered at the infinity central station (ics) between 16:30 and 20:30 while the patient was connected with 6 leads.Then the stcvm disappeared at the ics and on the infinity c500.The stvcm came back momentarily when the 12 lead electrocardiogram (ecg) was used but disappeared again when the monolead was removed.The stcvm was also not seen in symphony during these times.It was noted that the ecg was seen at all times with the correct leads.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
Multiple attempts were made to obtain additional information regarding the reported event; however, no additional information was provided.Without the device logs the reported event could not be confirmed.However, similar complaints have been previously reported and logs for those complaints were provided and, in these cases the root cause of the st values being temporarily unavailable was due to the neutral electrodes switching back and forth between leads due to the patient movement.The neutral electrode switching and motion artifact from the patient led to several instances of autoblocks, 4 second flat segments in the st waveforms.This behavior known as autoblock has been planned to be improved by draeger for a future software release.
Event or Problem Description
It was reported that the st change in vector magnitude (stcvm) was visible and trends were registered at the infinity central station (ics) between 16:30 and 20:30 while the patient was connected with 6 leads.Then the stcvm disappeared at the ics and on the infinity c500.The stvcm came back momentarily when the 12 lead electrocardiogram (ecg) was used but disappeared again when the monolead was removed.The stcvm was also not seen in symphony during these times.It was noted that the ecg was seen at all times with the correct leads.No adverse patient impact or death was reported.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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 ; 9784097390
• MDR Report Key: 20369085
• Report Number: 1220063-2024-00114
• Device Sequence Number: 17080155
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)131104(93)MS20401-14
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: MS20401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2013
• 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
• Patient Sex: Unknown