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

Catalog Number MS25520

Device Problems Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 335955104
• Report Number: 1220063-2024-00018
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)230921(17)231118(93)MS25520-71
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.