MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; VAPORIZER

Model Number 1388-800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

There is an instruction that states, "do not touch unit or steam vapor during use.Steam is hot and burns can occur." and consumer failed to perform that instruction.

Event Description

The consumer filed an incident report with the fda under reference number mw5086366 alleging that a humidifier/vaporizer caused a serious injury to the lower part of their arm.There was not a report of property damage with this incident.

• Brand Name: SUNBEAM
• Type of Device: VAPORIZER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.; no.1777 yangzi east road; chuzhou, 23900 0; CH 239000
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 8615844
• MDR Text Key: 145256563
• Report Number: 3010341502-2019-00035
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1388-800
• 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 Outcome(s): Other