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

Model Number	N/A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on (b)(6) 2024, the user found that the kappa could not monitor blood pressure under anesthesia, and reportedly affected the treatment process.It was reported that there was no harm to the patient, and that the department immediately replaced the patient monitoring device.No adverse patient impact or death was reported.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that the kappa monitor could not measure blood pressure during use.The department immediately discontinued use of the kappa and replaced it with a known good monitor to finish the surgical procedure.The customer reported that there was no harm to the patient due to the monitor issue.The customer performed an evaluation of the kappa monitor and the cause of the reported issue was found to be a faulty blood pressure module.The kappa was scheduled for repair at the customer's site.Multiple requests for additional information and the faulty blood pressure module were submitted.Draeger service was not involved with the incident so no information or the faulty part was made available.The root cause for the kappa monitor not measuring blood pressure was due to a faulty blood pressure module.There is no further information available.This complaint is being closed and if in the future, additional information becomes available a new complaint will be opened to document the new findings.
Event or Problem Description
The customer reported that on (b)(6) 2024, the user found that the kappa could not monitor blood pressure under anesthesia, and reportedly affected the treatment process.It was reported that there was no harm to the patient, and that the department immediately replaced the patient monitoring device.No adverse patient impact or death was reported.

• 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: 20013853
• Report Number: 1220063-2024-00101
• Device Sequence Number: 7257385
• Product Code: MHX
• UDI-Device Identifier: 04049098002172
• UDI-Public: (01)04049098002172(11)130221(93)MS25490-24
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Model Number: N/A
• Device Catalogue Number: MS25490
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2013
• 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