MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC IACS MONITORING WITH C700; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS25520
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported the draeger m540 rebooted.It was originally reported as a disconnect, but once on site, it was actually a m540 reboot and came back on.There was no report of an adverse event or patient injury.
Additional Manufacturer Narrative
It was reported that an m540 rebooted and came back on during a surgery.The customer replaced the iacs with a delta, and the draeger field service engineer (fse) pulled the logs.The fse installed a new ethernet cable, power supply and system connect board on the defunct ps2500.No additional information regarding how the malfunction was determined was provided.The logs were analyzed; however, the provided logs do not show enough information for the date of event to provide a root cause.The logs confirmed that there was an unexpected reboot on the date of event but cannot provide any detailed information.As neither specific device malfunction or log findings are available, a specific root cause could not be determined.The p2500 was determined to be the cause of the reboot, but the specific defect could not be determined.After repair, the fse performed a full preventive maintenance on the iacs system and when all tests passed, the fse placed the device back into service.
Event or Problem Description
The customer reported the draeger m540 rebooted.It was originally reported as a disconnect, but once on site, it was actually a m540 reboot and came back on.There was no report of an adverse event or patient injury.

• Brand Name: IACS MONITORING WITH C700
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18712662
• Report Number: 1220063-2024-00018
• Device Sequence Number: 7255979
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)230921(17)231118(93)MS25520-71
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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