MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH FHD MONITOR; LARYNGOSCOPE, RIGID

Model Number	0570-0437
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Verathon is conducting a voluntary correction for a limited number glidescope core 15 and core 15 fhd monitors.Verathon has received 12 complaints from customers about a loss of image when using a core 15 or core 15 fhd monitor in conjunction with unique combinations of the glidescope core 2m quickconnect cable (0600-0843) and spectrum qc single-use video laryngoscopes.No injuries have been reported.Verathon has implemented a correction in the form of a software update (core 15: v1.10 and core 15 fhd: v1.8) to prevent a loss of image.Verathon's investigation confirmed that with these unique combinations that a video signal delay issue can contribute to a degradation in image quality, a loss of image, or the airway cannot be visualized.This may lead to a delay in the procedure until a replacement or alternative device is obtained, which may cause serious injury.Following the reported event, the customer was provided the aforementioned software update for their glidescope core 15-inch fhd monitor.To date, no other issues have been reported.Verathon will continue to monitor for ongoing trends.
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core 15-inch fhd monitor, the screen displays green lines and they could not see anything.It was also reported that sometimes the picture would blink in and out.No delay in procedure, use of a backup device, or harm to the patient was reported.

• Brand Name: GLIDESCOPE CORE 15-INCH FHD MONITOR
• 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: 20076684
• Report Number: 9615393-2024-00113
• Device Sequence Number: 6414530
• Product Code: CCW
• UDI-Device Identifier: 00879123008596
• UDI-Public: (01)00879123008596(11)231212
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall,Modification/Adjustment,Notification
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: 0570-0437
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2022-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown