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

Catalog Number	MS18853
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the screen of the infinity kappa patient monitor went black during a surgery when the patient under anesthesia.During this period, vital signs were monitored manually by palpating the carotid pulse and auscultating the heart.Out of concern for potential changes in the patient¿s condition, the surgical procedure was temporarily paused, and a spare monitor was deployed to allow the operation to proceed successfully.A third-party performed an initial assessment of the affected kappa and found there was a malfunction of the central processing unit (cpu) in the display screen.It was also noted that the device later passed maintenance testing and was put back into use.Draeger service was not involved and evidence of the device evaluation and testing that was performed was not provided.Additional information regarding this event was requested, but no further information was made available.
Event or Problem Description
It was reported that the infinity kappa monitor was used by the anesthesiologist to monitor the vital signs of a patient who was under general anesthesia.After the endotracheal intubation and surgical draping was performed, the monitor screen suddenly blacked out and the anesthesiologist could no longer adjust the anesthesia depth based on the patient's vital signs.They relied on palpitation of the carotid pulse and cardiac auscultation to monitor the patient's condition; however, due to concerns about undetected changes in the patient's status, the surgeon did not want to proceed with the operation without a functional monitor.The kappa was restarted, and the cables were reconnected to troubleshoot the issue; however, the issue persisted.The effected monitor was replaced with a backup monitor to continue the surgery.No patient injury was reported.

• Brand Name: INFINITY KAPPA MONITOR
• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784090504
• MDR Report Key: 22359435
• Report Number: 1220063-2025-00033
• Device Sequence Number: 15466980
• Product Code: MHX
• UDI-Device Identifier: 04049098004039
• UDI-Public: (01)04049098004039(11)170213(93)MS18853-55
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2013
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown