MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY KAPPA MONITOR; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Model Number	MS18853
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hospital technician found the low-voltage differential signaling (lvds) connection cable was loose, reconnecting the cable resolved the issue.No device malfunction was identified.The device was returned to use.H3 other text : the device was evaluated on site with no malfunctions identified.
Event or Problem Description
It was reported that when the anesthesiology department used the monitor to monitor the vital signs of patients undergoing ophthalmic surgery, the screen suddenly went black.After the equipment maintenance engineer arrived, he used an external display screen for the operation to continue.Though no adverse patient impact was reported, a delay in treatment cannot be excluded for having occurred.

• Brand Name: INFINITY KAPPA MONITOR
• 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
• MDR Report Key: 17409874
• Report Number: 1220063-2023-00025
• Device Sequence Number: 14933253
• 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: K070566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MS18853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown