MAUDE Adverse Event Report: AMBU A/S AMBU AVIEW 2 ADVANCE

Model Number 405011000

Device Problem Fire (1245)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the customer report, the supplied images and the report from the fire department we conclude that the root cause is that the internal lithium-ion battery was penetred by a 30mm screw during the cart mounting process.The product risk evaluation for aview 2 advance was reviewed and it was identified that the issue is not currently covered.A capa (ca-000810) was initiated to futher assesses and document the issue.

Event Description

An aview 2 advance (405011000) was mounted on an acart compact (ku.9713.800) using the vesa mounting, when the av2a caught on fire.The customer was mounting an aview 2 advance to an acart with a vesa mount from the mounting kit being delivered with the acart.According to customer the av2a started to spark and caught fire evolving to a "fireball" when the last screw was mounted.No patient or user was harmed.

• Brand Name: AMBU AVIEW 2 ADVANCE
• Type of Device: AMBU AVIEW 2 ADVANCE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• MDR Report Key: 17258349
• MDR Text Key: 318393509
• Report Number: 1220828-2023-00013
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2023,07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 405011000
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other