MAUDE Adverse Event Report: VERATHON INC. VERATHON GLIDE SCOPE LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

Patient Problems Aspiration/Inhalation (1725); Low Oxygen Saturation (2477)

Event Date 10/27/2020

Event Type  Injury  

Event Description

Hdmi cable malfunction of glidescope with loss of signal due to insecure physical interface caused image loss during endotracheal intubation resulted in aborted rapid sequence intubation and sustained hypoxia in the 20%-30% spo2 range as well as aspiration event.Morbid obese patient undergoing urgent surgery for perforated appendicitis with abscess.Fda safety report id# (b)(4).

• Brand Name: VERATHON GLIDE SCOPE LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON INC.
• MDR Report Key: 10755673
• MDR Text Key: 213925137
• Report Number: MW5097543
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR
• Patient Weight: 198