MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4; LARYNGOSCOPE, RIGID

Model Number 0574-0188

Device Problem Erratic or Intermittent Display (1182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The customer was unable to have the reported glidescope spectrum single-use directview mac s4 laryngoscope returned to verathon for evaluation as it had already been discarded at their facility.However, a verathon sales representative went on-site to assist the customer with troubleshooting the reported issue by connecting three different blades to the same glidescope core smart cable used during the reported event and manipulating the blade and cable connection but was unable to recreate the reported image issue.While the exact cause could not be determined, it is likely that the issue was isolated to just the mac s4 blade used during the procedure.Upon completion of the evaluation by the verathon sales representative, the customer's smart cable was returned to service at their facility.No further investigation is required at this time.Verathon will continue to monitor for trends.

Event Description

A customer reported that during an emergency care procedure, using a glidescope spectrum single-use directview mac s4 laryngoscope, the light was cutting in and out when advancing the blade causing the screen to go black intermittently.The procedure was completed using a glidescope spectrum single-use directview mac s3 laryngoscope, which was made available in an unspecified amount of time, and at which point the patient started desaturating.No harm to the patient was reported.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4
• 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: 15845718
• MDR Text Key: 307994679
• Report Number: 9615393-2022-00210
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2022

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
• Device Operator: Health Professional
• Device Model Number: 0574-0188
• Device Catalogue Number: 0270-0933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1