MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 15-INCH MONITOR; LARYNGOSCOPE, RIGID

Model Number 0570-0404

Device Problem Overheating of Device (1437)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The reported glidescope core 15-inch monitor was returned to verathon for evaluation due to the initially reported charging/power management issue.A verathon technical service representative was able to confirm the reported battery charging issue in addition to identifying evidence of a thermal event on and around the internal battery assembly.The identified thermal damage included the battery's wires, the battery's plastic, and the interior of the monitor's housing.Due to the identified damage, verathon provided the customer a replacement monitor.Verathon notified the supplier of the glidescope core 15-inch monitor who performed a failure analysis.Verathon also coordinated an additional investigation of the damaged monitor which was completed by an independent third-party laboratory.Investigation findings indicate that the failure was caused by a mechanical short circuit between energized battery components and nearby conductive materials.It was not the result of an electrochemical failure within one or more of the battery cells.The mechanical short was caused by portions of the connector tab between the battery's cells penetrating the battery's shrink wrap and contacting conductive portions of the device's frame.Observations made during the investigation also indicated no visible signs of thermal damage were apparent from the exterior of the monitor, confirming that the thermal event was retained internally within the monitor and isolated to the battery assembly and adjacent components.Review of complaint history for the reported monitor serial number "(b)(4)" did not identify any previous complaints.Review of complaint history in the past ten years for all verathon battery-powered monitors did not identify any similar incidents or trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous situation has been adequately captured and characterized.Verathon will continue to monitor for trends.

Event Description

A verathon technical service representative reported that during a device evaluation of a customer's returned glidescope core 15-inch monitor, evidence of a thermal event on and around the internal battery assembly was identified.The initial reported issue identified by a verathon sales representative while on-site at the customer's facility, reported that the monitor would not stay charged and would power off immediately after being unplugged from its power source.Upon identifying the power issue with the device, neither the verathon sales representative nor the customer reported any occurrence of a thermal event or notice any evidence to the internal thermal damage later found inside the monitor.

• Brand Name: GLIDESCOPE CORE 15-INCH MONITOR
• 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: 15855446
• MDR Text Key: 305630813
• Report Number: 9615393-2022-00207
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00879123006639
• UDI-Public: 010087912300663911220318
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2022

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: Other
• Device Model Number: 0570-0404
• Device Catalogue Number: 0270-1033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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