MAUDE Adverse Event Report: VERATHON MEDICAL ULC; LARYNGOSCOPE, RIGID

Device Problem No Display/Image (1183)

Patient Problems Aspiration/Inhalation (1725); Hypoxia (1918)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Since the customer and device information was not provided on the initial manufacturer and user facility report, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted in accordance with 21 cfr 803.56.

Event Description

This issue was reported via manufacturer and user facility report number mw5097543 which stated the image on an unspecified glidescope device had disappeared during an endotracheal intubation.The report noted that the hdmi connector malfunctioned causing an insecure physical interface which resulted in image loss.The aborted rapid sequence intubation caused a sustained hypoxia in the 20%-30% spo2 range as well as an aspiration event.There is no indication of how the event was resolved.No harm to the patient or user was reported.

• 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 98011-8218 ; 4256295760
• MDR Report Key: 11013559
• MDR Text Key: 221898584
• Report Number: 9615393-2020-00268
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/28/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention