MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC POCKET MONITOR SET

Model Number 8403XDK

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2023

Event Type  Death  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that during a reanimation the image of the video laryngoscope disturbed 2 times which caused a delay of 4mins and 2 interruptions of the intubation.The procedure was completed with a spare device.According to the information received, the patient passed.According to the new information, the malfunction of the device has not caused the death of the patient.Nevertheless, the product has not yet been investigated therefore, and due to the death of the patient, the case is still reportable.

• Brand Name: C-MAC POCKET MONITOR SET
• Type of Device: C-MAC POCKET MONITOR SET
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18384510
• MDR Text Key: 331233735
• Report Number: 2020550-2023-00403
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551396186
• UDI-Public: 4048551396186
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8403XDK
• Device Catalogue Number: 8403XDK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death