MAUDE Adverse Event Report: GREAT GROUP MEDICAL CO LTD RESIPRATORY HUMDIFIER HEATER - 100-120V WITH NEMA 5-15P 3 PIN PLUG; RESPIRATORY HUMDIFIER HEATER

Catalog Number FL9000U

Device Problem Fire (1245)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

The heater was not heating and alarming.The facility turned it off and unplugged the heater, they plugged into a different outlet and turned it back on and it seemed to work fine and heat up.They changed it to niv mode and patient started pointing to heater because it had smoke coming out of it, then caught on fire.

Manufacturer Narrative

The device is being returned for evaluation.Once returned an investigation into root cause will be conducted.

• Brand Name: RESIPRATORY HUMDIFIER HEATER - 100-120V WITH NEMA 5-15P 3 PIN PLUG
• Type of Device: RESPIRATORY HUMDIFIER HEATER
• Manufacturer (Section D): GREAT GROUP MEDICAL CO LTD; no. 168 xingong 2nd rd.; tianzhong township; changua county 520, taiwan ; TW
• Manufacturer (Section G): GREAT GROUP MEDICAL CO. LTD; no. 168 xingong 2nd rd.; tianzhong township; changhua county 520, taiwan ; TW
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 13042628
• MDR Text Key: 282485695
• Report Number: 3006061749-2021-00012
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: FL9000U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• 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: Reuse
• Removal/Correction Number: MW5105695
• Patient Sequence Number: 1