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

Model Number 405011000

Device Problem Fire (1245)

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

Event Type  malfunction  

Manufacturer Narrative

The monitor was not received for investigation since it was disposed of by fire brigade.Pictures was provided.Investigation is still ongoing.The event is suspected to be caused by the impact on the battery when the monitor was dropped onto the floor.

Event Description

The aview 2 advance display unit was dropped from approximately 1.5 meters.Sparks was observed and the monitor caught fire.The display left a burn mark on the floor.Fire brigade was called to handle the monitor and disposed it.Patient was not involved.No harm to user.

• Brand Name: AVIEW 2 ADVANCE
• Type of Device: AVIEW 2 ADVANCE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): BRITEMED TECHNOLOGY INC.; 3f, no.306, sec. 1; datong rd; xizhi city, taipei country 221 ; TW 221
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16387146
• MDR Text Key: 309673809
• Report Number: 9610691-2023-00006
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 405011000
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other