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

Catalog Number	MK31501
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ongoing cpr the patient monitoring system failed to provide eco2 data which made clinical decisions in this situation more challenging.It was confirmed the resuscitation was successful that the patient was transferred to the icu.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Additional Manufacturer Narrative
T was reported the etco2 was functioning when undocked but once the m540 is docked, the etco2 reading disappears.A spare m540 was installed which replicated the reported issue then a spare m500 was installed.Once the m500 was put into place, the m540 was able to be docked while still displaying the etco2 readings.Upon draeger's receipt of the iacs, the system was evaluated where it was confirmed the cause of the issue was due to a faulty daughterboard.The daughterboard (pcb m500 daughter brd v7) was replaced in the m500 then sent back to the customer for use.
Event or Problem Description
It was reported that during an ongoing cpr the patient monitoring system failed to provide eco2 data which made clinical decisions in this situation more challenging.It was confirmed the resuscitation was successful that the patient was transferred to the icu.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 17884010
• Report Number: 1220063-2023-00035
• Device Sequence Number: 7289492
• Product Code: MHX
• UDI-Device Identifier: 04049098009751
• UDI-Public: 04049098009751
• 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): 05/01/2024

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: MK31501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2015
• 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.
• Patient Sex: Unknown