MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE SMART CABLE; LARYNGOSCOPE, RIGID

Model Number	0600-0783
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/21/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The reported glidescope core smart cable was returned to verathon for evaluation along with the glidescope core 10-inch monitor (serial number: (b)(6) used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported failure.Partial plastic was missing from the hdmi connector housing and two (2) hdmi pins were damaged.When connecting the smart cable to verathon's test equipment, it produced an intermittent image.The customer's smart cable failed verathon's device functionality testing.The customer's returned monitor passed visual inspection and verathon's device functionality testing.When connected to verathon's test equipment, it produced a normal image and was confirmed to be functioning as intended.Upon completion of verathon's device evaluation, a replacement glidescope core smart cable was provided to the customer along with returning their monitor that was evaluated.The laryngoscope used with the smart cable during the reported event was not made available to verathon for evaluation.While the patient involved in this event ended up passing away, they were reported to be experiencing a cardiac arrest and therefore needing to be intubated.The facility reported that the patient death did not occur during the intubation procedure itself.The facility did not report that the device malfunction caused or contributed to the cardiac arrest nor to the patient's death.Verathon has not received any reports alleging patient or user harm as a result of this failure mode.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported while using a glidescope core smart cable during intubation of a patient experiencing cardiac arrest, the video flickered in and out.It was reported that the patient ended up passing away.The facility reported that the patient death did not occur during the intubation procedure itself.Follow-up information received from the facility's patient care manager reported that they were not able to complete the procedure with the original device.The procedure was delayed approximately three (3) minutes.It was reported that a glidescope spectrum single-use s3 laryngoscope (unknown model and lot number) was connected to the original glidescope core system for the procedure.The facility declined to provide any further information about the patient involved or whether they were able to successfully complete the procedure using a backup device "due to hipaa reasons.".

• Brand Name: GLIDESCOPE CORE SMART CABLE
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 20273168
• Report Number: 9615393-2024-00120
• Device Sequence Number: 17004740
• Product Code: CCW
• UDI-Device Identifier: 00879123006752
• UDI-Public: (01)00879123006752(11)230717
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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: Death
• Patient Sex: Unknown