MAUDE Adverse Event Report: GUARDIAN TECHNOLOGIES GERMGUARDIAN AC5000E 3-IN-1 TRUE HEPA AIR PURIFIER SYSTEM WITH UV AND ODOR REDUC; HUMIDIFIER

Model Number AC5000E

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2017

Event Type  No Answer Provided  

Event Description

We have a germguardian ac5000e.One evening while watching a movie, we smelled a hot electrical smell.We started running around looking for what it might be and found it to be the air purifier.We immediately turned it off.Then while looking at (b)(4) reviews to see if it happened to anyone else, we found others complain about a fire and about a burnt board.I then took our unit apart and found a burnt board.I have no doubt that if we were not home or asleep at the time, it would have caught on fire.I did take pictures of the burnt board.(b)(4).Purchase date: (b)(6) 2016.

• Brand Name: GERMGUARDIAN AC5000E 3-IN-1 TRUE HEPA AIR PURIFIER SYSTEM WITH UV AND ODOR REDUC
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): GUARDIAN TECHNOLOGIES
• MDR Report Key: 6307510
• MDR Text Key: 66928156
• Report Number: MW5067701
• Device Sequence Number: 1
• Product Code: KFZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AC5000E
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1