MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY KAPPA; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS18853
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on (b)(6) 2023, the patient required the use of the cardiac monitor to monitor the vital signs during surgery.It was noted that there was no abnormality observed during the use, but the operator found that the ecg leads could not be displayed normally as there was interference.The use of the kappa monitor was immediately stopped and replaced by another one.There is no report of patient harm or adverse event.
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 on (b)(6) 2023, the patient required the use of the cardiac monitor to monitor the vital signs during surgery.It was noted that there was no abnormality observed during the use, but the operator found that the ecg leads could not be displayed normally as there was interference.The use of the kappa monitor was immediately stopped and replaced by another one.There is no report of patient harm or adverse event.
Additional Manufacturer Narrative
As per report, the device was used for monitoring during a surgical procedure and was initially working without restrictions until interference on the ecg trace has occurred.Reportedly, the disturbance could be eliminated by replacing the monitor and ecg cable; the hospital could later draw a causal connection between the observations and the ecg cable.It was confirmed by the hospital that the surgical procedure could be continued with no delay and that there was no negative influence that affected the patient.The user facility did not involve the local dräger s&s organization into any follow-up measures and did not respond to requests for further information.The suspected ecg lead wires were also not returned.This does neither allow a case-specific evaluation nor a reliable conclusion about the exact root cause for the event.Dräger concludes the following: the source of interference must have been another product among the set-up used during the surgery.Based on experience, such interference may occur when an electrosurgical device will be activated.It would be plausible that the immunity barriers of the monitor against electromagnetic interference may have been compromised due to a defective shielding at the ecg cable.The event may also have been related to other factors; a differentiation is not possible due to lack of information.

• Brand Name: INFINITY KAPPA
• 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: 18702385
• Report Number: 1220063-2024-00017
• Device Sequence Number: 6144135
• Product Code: MHX
• UDI-Device Identifier: 04049098004039
• UDI-Public: (01)04049098004039(11)200909(93)MS18853-65
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 03/27/2024

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: MS18853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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: Female