MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (B-TT)

Model Number FL9000U

Device Problem Insufficient Information (3190)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

The event details were described as 'one device was not functioning when it was received.It kept alarming open circuit.The other device appeared to be working but was not heating up "although" it was giving temperature readings.'.

• Brand Name: RESPIRATORY HUMIDIFIER HEATER 100-120V WITH NEMA 5 - 15P 3 PIN PLUG
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) (B-TT)
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cynon valley business park; mountain ash, CF454 ER; UK CF454ER
• Manufacturer (Section G): GREAT GROUP MEDICAL CO. LTD; no. 168 xingong 2nd rd.; tianzhong township; changhua county 520, taiwen ; TW
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 15866666
• MDR Text Key: 307895220
• Report Number: 3006061749-2022-00018
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/25/2022

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 Model Number: FL9000U
• Device Catalogue Number: FL9000U
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1