MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC IACS MONITORING WITH C700; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number	MS25520
Medical Device Problem Codes	No Device Output (1435); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
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 that the or department to inform us that a second m540 is failing to display ecg information on the iacs.The cables were changed without any luck.The first unit was swapped the previous unit waiting for the unit to be repaired.There was no report of an adverse event or patient injury.
Event or Problem Description
The customer reported that the or department to inform us that a second m540 is failing to display ecg information on the iacs.The cables were changed without any luck.The first unit was swapped the previous unit waiting for the unit to be repaired.There was no report of an adverse event or patient injury.
Additional Manufacturer Narrative
It was reported there was no ekg tracing on either the m540 or the c700.Replacing the ekg cable and leads reportedly did not resolve the issue.Ekg tracings were available once the customer replaced the m540 with a spare.A field service engineer (fse) went onsite to perform testing on the m540 by connecting the device to an ecg simulator where it was confirmed one set of ecg leads were faulty.All other sets of ecg leads were fully functional.The m540 and cockpit were both found to be functioning properly and returned back to service for use.The error condition was clearly attributed to the cable.The conflict to the user's report that the cable exchange did not remedy the issue during the course of the event could not be removed.

• Brand Name: IACS MONITORING WITH C700
• 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18703129
• Report Number: 1220063-2024-00019
• Device Sequence Number: 7217554
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)181105(17)190306(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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2018
• 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
• Patient Sex: Unknown