MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. HOLMES; HUMIDIFIER

Model Number HM5082

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 01/06/2024

Event Type  malfunction  

Event Description

An insurance company is making a subrogation claim under case reference number (b)(4) and alleging that a humidifier was the cause of a fire that damaged its insured's property.There was not a report of personal injury with this incident.

Manufacturer Narrative

There is an instruction that states, "household use only" and consumer failed to perform that instruction.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 6655 peachtree dunwoody rd.; atlanta GA 30328
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS. CO; no. 9112, hung yeh 8th road; tangxia town ; CH
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 18880834
• MDR Text Key: 337465274
• Report Number: 3003862163-2024-00022
• Device Sequence Number: 1
• Product Code: KFZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HM5082
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown