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

Model Number 405011000

Device Problem Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

Initial investigation shows that physical impact has occured for the monitor showing signs of rough handling/being dropped, the cause of the problem is therefore expected to be related to the battery breaking loose after several severe physical impacts, such as dropping the unit on the floor from table height.When the battery is loose, it may after repeated physical impacts scratch a whole in the battery pack insulation, which may again cause a short-circuit to a metal screw in the cabinet which may lead to smoke or fire.It is therefore likely that the smoke has been caused by a short-circuit in the low-charged battery which was being charged.When the charger was unplugged, the energy supply for the battery stopped, and the smoke stopped as well.Should further investigation change the above conclusion this report will be updated accordingly.Patient was not involved and there was no harm to user or third party.

Event Description

According to customer "when walking into the room it smelled burning.The monitor was plugged in and placed on a shelf with the back of the monitor facing upwards.Smoke was coming from the vent area of the monitor.Monitor was unplugged and powered off and thereafter stopped emitting smoke.".Patient was not involved.No harm to user or third party.

• 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 road; xizhi city, pei country 221 ; TW 221
• Manufacturer Contact: kristine rasmussen ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16403097
• MDR Text Key: 309987486
• Report Number: 9610691-2023-00009
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2023

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: Other
• Device Model Number: 405011000
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other