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

Catalog Number	MS25520
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
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 cockpit of the patient monitoring system performed a reboot during use.The bedplace monitor continued to monitor the patient.No patient consequences were resulting form the event.
Event or Problem Description
It was reported that the cockpit of the patient monitoring system performed a reboot during use.The bedplace monitor continued to monitor the patient.No patient consequences were resulting form the event.
Additional Manufacturer Narrative
It was reported that a provider noticed loss of waveforms on the c700 then a blank screen.The c700 went into a restart, completed its restart, connected to m540, all parameters came back normal.No disconnect or loss of patient data on m540.Root cause was identified as pdr (patient data repository) deadlock.The logs and device were analyzed and found that the cockpit reboot was due to a pdr (patient data repository) deadlock.The specific cause of the pdr deadlock cannot be determined but is more likely to occur with the gen 2 kontron cockpit used by the customer due to its cpu.The gen 2 kontron has a software error, and the newer cockpit models have reduced the deadlock issue with better cpu capabilities.The cockpit reboot is the workaround for the pdr deadlock, and the device is working as designed.The reboot is the workaround of the issue currently for this cockpit.To eliminate the issue further, the customer can decide to replace the cockpits.

• 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 ; 9783798000
• MDR Report Key: 18090476
• Report Number: 1220063-2023-00040
• Device Sequence Number: 6680792
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)180919(17)190107(93)MS25520-51
• 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): 09/16/2024

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: 10/10/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2018
• 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