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

Catalog Number	UNKNOWN
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was a "dropout" between the m540 and c500 "every few seconds" on (b)(6) 2024 at 12:30.The customer reconnected the m540 to another m500 which did not resolve the issue, and then attempted with a new m540 which also had the same issue.Then the customer placed the original m540 on the original m500, and the fault had cleared with no reoccurrence since.No adverse patient impact or death reported.
Additional Manufacturer Narrative
A complaint was received involving a c500 that was losing connection to an m540.It was reported that a patient that was being monitored in a recovery bed at the time of the dropouts and was moved to another bedspace with the m540 that continued to monitor.No adverse patient impact was reported.After further review of the log files by a draeger escalation support, the (b)(6) 2024 email stated that the root cause was identified as a previously determined software issue.The attached fit investigation report explains this can occur when the infinity waveform system that handles the transmitting and plotting of waveform parameters, stacks up waveform ids (the waveform id's to be assigned reach the iws reserved value) and the cockpit then sends a disconnect to the m540 in order to prevent old waveform id's from displaying, generating a disconnect error message.The number of times an m540 is docked and undocked without rebooting the cockpit contributes to this series of "stacking" waveform ids.The m540 is unaffected by this software bug and will continue to monitor the patient.According to the product manager's 23aug24 email response this software issue has been fixed with the iacs vg8 and the current work around for this issue is to rebook the cockpit to clean up the process.This was further confirmed by the local tss in the 16july24 email response that the users should reboot the cockpit more frequently than they currently do to prevent this disconnect.The prmr (product risk management report) was reviewed, and no new risks were identified.Thorsw-56960 was opened to evaluate the issue further.
Event or Problem Description
The customer reported that there was a "dropout" between the m540 and c500 "every few seconds" on (b)(6) 2024 at 12:30.The customer reconnected the m540 to another m500 which did not resolve the issue, and then attempted with a new m540 which also had the same issue.Then the customer placed the original m540 on the original m500, and the fault had cleared with no reoccurrence since.No adverse patient impact or death 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 ; 9784828529
• MDR Report Key: 19885652
• Report Number: 1220063-2024-00096
• Device Sequence Number: 7283595
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)190402(93)MK32500-02
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: UNKNOWN
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown