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

Model Number GLIDESCOPE VIDEO MONITOR

Device Problems Smoking (1585); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2013

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: battery failure and burning/smoke damage was confirmed.Plugged in power cord to unit to attempt to charge battery.Battery led started flashing indicating battery failure.Opened pgvl monitor and replaced faulty battery.Examined all pcbas and found a component on the lcd pcba had blown.Replaced faulty lcd.Reassembled monitor.Discharged new battery and recharged.Monitor is now functioning properly.The product was evaluated for the reported malfunction and the malfunction will be tracked and trended to determine any additional actions.

Event Description

Customer reported, during inspection, the charge light was blinking and monitor beeping.Biomed noted at one point when he turned it on, he saw some smoke come out of it.Attempted troubleshooting and found that the light went solid for about 5 minutes and then went back to blinking, biomed said he can turn it on and see that it is back lit but there isn't anything else on the screen.Plugged in power cord to unit to attempt to charge battery.Battery led started flashing indicating battery failure.No patient involvement.

• Brand Name: GLIDESCOPE VIDEO MONITOR
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, bc V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: brian anderson ; 20001 north creek parkway; bothell, WA 98011 ; 4256295674
• MDR Report Key: 5262755
• MDR Text Key: 32580001
• Report Number: 9615393-2015-00066
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLIDESCOPE VIDEO MONITOR
• Device Catalogue Number: 0570-0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2008
• 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