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

Model Number 405011000

Device Problems Fire (1245); Smoking (1585); Sparking (2595); Device Fell (4014)

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

Event Date 12/23/2022

Event Type  malfunction  

Manufacturer Narrative

From the images we conclude that the battery has exploded/caught fire caused by the shock from falling 2-3 feet.

Event Description

The aview 2 advance display unit was dropped from approximately 2-3 ft.And landed on the screen.The device started smoking upon impact and flames was seen.A patient in the vicinity was evacuated, a blank was thrown over the device and a fire extinguisher was then used.Patient outcome was not affected.

Manufacturer Narrative

From the images we conclude that the battery has exploded/caught fire caused by the shock from falling 2-3 feet.Follow up to (b)(6) 2023: the report has been reviewed to include all the following relevant medical device problem codes: 1585 , 2595 , 1245 , 4014.

Event Description

The aview 2 advance display unit was dropped from approximately 2-3 ft.And landed on the screen.The device started smoking upon impact and flames was seen.A patient in the vicinity was evacuated, a blank was thrown over the device and a fire extinguisher was then used.Patient outcome was not affected.

• Brand Name: AVIEW 2 ADVANCE
• Type of Device: AVIEW 2 ADVANCE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark 2750 ; DA 2750
• Manufacturer (Section G): BRITEMED TECHNOLOGY INC; 3f, no.306, sec. 1, datong rd; xizhi city, tapei country 221 221 ; TW 221
• Manufacturer Contact: giulia salierno ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16221013
• MDR Text Key: 308081173
• Report Number: 9610691-2023-00001
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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: Health Professional
• Device Model Number: 405011000
• Device Catalogue Number: 405011000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/21/2023
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other