MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE® RANGER SINGLE USE SYSTEM; LARYNGOSCOPE, RIGID

Model Number 0570-0186

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

A verathon customer care supervisor followed up with the customer to provide additional information.The customer was advised that the glidescope ranger video monitor is not a user repairable device.Per the glidescope ranger operations and maintenance manual (omm), "the battery is not user replaceable.In case of battery malfunction, do not attempt to replace the monitor battery.Any attempts to replace the battery by unauthorized service technicians may cause serious harm to the user and will void the warranty." the customer purchased a replacement device and was advised to dispose of the damaged battery according to applicable local and state laws.While the device was not returned to verathon for evaluation, it was determined that the cause of the reported issue was due to the unauthorized repair performed by the customer.No corrective action is required at this time.Verathon continues to monitor for trends.

Event Description

The customer reported that during a battery replacement on their glidescope ranger video monitor, the biomedical engineer damaged the battery, resulting in the battery catching on fire.The fire was put out by the biomedical engineer using a fire extinguisher and no harm to the user was reported.

• Brand Name: GLIDESCOPE® RANGER SINGLE USE SYSTEM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 9177424
• MDR Text Key: 161917567
• Report Number: 9615393-2019-00135
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0186
• Device Catalogue Number: 0570-0186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• 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