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

Model Number 0800-0604

Device Problems Display or Visual Feedback Problem (1184); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during an emergency care procedure, using a glidescope core video cable, the screen flickered and then went back to the start up screen as if there were no blades attached.The customer's biomed stated that the end-user thought the problem was the cable.An unknown delay in the procedure occurred as an unidentified backup device was obtained.No harm to the patient or user was reported.

• Brand Name: GLIDESCOPE CORE VIDEO CABLE
• Type of Device: 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 ; 6295760
• MDR Report Key: 10382172
• MDR Text Key: 203175116
• Report Number: 9615393-2020-00123
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0800-0604
• Device Catalogue Number: 0800-0604
• Device Lot Number: 13149-1-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1