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

Model Number MS18853

Device Problem No Display/Image (1183)

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

Event Date 07/13/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 319923896
• Report Number: 1220063-2023-00025
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004039
• UDI-Public: (01)04049098004039(11)170213(93)MS18853-55
• Combination Product (y/n): N
• PMA/PMN Number: K070566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MS18853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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
• Patient Outcome(s): Other