MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC KAPPA; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number	MS18853
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the kappa screen "greyed out" during surgery, and that the audible prompts and alarms were stuff present.There was no report of patient injury or death.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
On 16may2024 draeger service inspected the device and confirmed the reported issue.The service engineer observed that they could hear the power supply continuously discharge and there was no output from the connector.It was discovered that the power supply had failed.A replacement display was ordered.On 17may2024, once the replacement part had arrived, the new display was installed, and the power supply was replaced.The screen resolution was adjusted and then startup of the device was verified.The device was booted up multiple times to confirm proper operation.The device was then tested and confirmed to operate per the manufacturer's specifications.A root cause for the greyed-out display was able to be traced to a failed power supply.The power supply and display were replaced to resolve the issue.A specific root cause for why the power supply failed was unable to be confirmed with the information made available in this investigation.
Event or Problem Description
The customer reported that the kappa screen "greyed out" during surgery, and that the audible prompts and alarms were stuff present.There was no report of patient injury or death.

• Brand Name: KAPPA
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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 ; 9784828529
• MDR Report Key: 19404029
• Report Number: 1220063-2024-00064
• Device Sequence Number: 17879198
• Product Code: MHX
• UDI-Device Identifier: 04049098004039
• UDI-Public: (01)04049098004039(11)131118(93)MS18853-37
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown