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 09/19/2023

Event Type  malfunction  

Event Description

Monitor was being installed on a new roll stand cart that was just purchased for it (roll stand was made for monitor and purchased from mfr).User was screwing the monitor onto the stand and it was a bit loose so he was unscrewing to make it tighter and as he unscrewed it started to spark and caught on fire.Flame was put out by the users using a fire extinguisher and the fire department came and took the device outside.The user never met any resistance while screwing or unscrewing.

Manufacturer Narrative

Based on the customer report, the supplied images and the information from the technician, we conclude that the root cause is that the internal lithium-ion battery was penetrated by a 30mm screw during the cart mounting process.The product risk evaluation for aview 2 advance was reviewed and the risk r230-01 adresses the risk of vesa mounting resulting in a battery fire.This incident did not result in any user or patient harm so there is no basis for changing the current severity and probability of r230-01.There is an ongoing capa (ca-000810) in order to futher assesses and document the issue.We are currently in communication with fda officer from division dht3a/oht3 on remedial actions.

• Brand Name: AMBU AVIEW 2 ADVANCE
• Type of Device: AMBU 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: lenka vaculciakova ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 17965812
• MDR Text Key: 326052029
• Report Number: 9610691-2023-00024
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• 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
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other