MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE MILLER S0 LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0202

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2024

Event Type  malfunction  

Manufacturer Narrative

Replacement glidescope spectrum single-use miller s0 laryngoscopes were provided to the customer and nine (9) glidescope spectrum single-use miller s0 laryngoscopes were returned to verathon for evaluation.Two (2) of the laryngoscopes were opened and seven (7) remained unopened.A verathon technical service representative evaluated the two opened laryngoscopes and was able to confirm the reported failure with one of them.When connected to known, good, test verathon equipment, the laryngoscope initially produced a normal image.Once the hdmi connection between the laryngoscope and test cable was manipulated, the image split multiple times and then the video feed stopped responding.The laryngoscope failed verathon's device functionality testing.The second laryngoscope evaluated produced a normal image continuously and passed verathon's device functionality testing.Upon completion of verathon's evaluation, the glidescope spectrum single-use miller s0 laryngoscopes were scrapped due to the customer already being provided repalcements and there being no repairs available for these devices.Corrective action is not 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 miller s0 laryngoscope, the screen on the connected glidescope go monitor would turn on when the laryngoscope was connected but then immediately lose the picture.The laryngoscope was then connected to a backup glidescope go monitor but with the same result.It was reported that the incident occurred after return of spontaneous circulation (rosc) and prior to transport of the patient.After unsuccessful intubation attempts were made, the patient's airway was maintained with a bag valve mask (bvm).No harm to the patient was reported.Following the incident, the customer reported testing both glidescope go monitors with a glidescope spectrum single-use s4 laryngoscope and confirmed the monitors worked as intended, therefore isolating the issue to the glidescope spectrum single-use miller s0 laryngoscope used during the reported incident.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE MILLER S0 LARYNGOSCOPE
• 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: 18740224
• MDR Text Key: 335812387
• Report Number: 9615393-2024-00036
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 0574-0202
• Device Catalogue Number: 0270-0966
• Device Lot Number: GQ98636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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