MAUDE Adverse Event Report: AMBU A/S AMBU AVIEW 2 ADVANCE; ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)

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 12/20/2022

Event Type  malfunction  

Event Description

Patient status post right redo microvascular decompression with glycerin rhizotomy was recovering when the anesthesiologist rounded to check on the patient.During the conversation the ambu aview 2 advance endoscopy monitor was placed on a trash can at patient bedside when it fell to the ground.Upon impact the monitor started to smoke and spark.The resident threw a blanket over the smoking/sparking monitor when it caught fire.The rn at the bedside retrieved the fire extinguisher and put out the flames and the fire alarm was initiated.The ambu aview 2 endoscopy monitor shorted, sparked and smoked upon impact to the floor causing the unit to be filled with electrical smoke.There were also remnants of chemical dry foam from the fire extinguisher that was used on the unit to put out the smolder from the unit.

• Brand Name: AMBU AVIEW 2 ADVANCE
• Type of Device: ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)
• Manufacturer (Section D): AMBU A/S; 6721 columbia gateway drive; suite 200; columbia MD 21046
• MDR Report Key: 16077892
• MDR Text Key: 306429675
• Report Number: 16077892
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 405011000
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1