MAUDE Adverse Event Report: VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD NEBULIZER HEATER 1/CS; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number 2M8021

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by vyaire that the complaint sample is not available for evaluation.Multiple attempts have been made to gain additional information from the customer and end user regarding the situation reported with the device.If a sample or any additional information becomes available a follow up report will be submitted.

Event Description

The customer reported a staff member suffered first degree burns while handling the heated nebulizer.The device was in use on patient when the issue occurred.However, there was no harm to the patient.The customer did not isolate the device after use so it is not available for return at this time.

• Brand Name: NEBULIZER HEATER 1/CS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD; 45-46 shabu industrial zone; qiaolong district, tangxia; dong guan guangdong,523730 ; CH
• Manufacturer (Section G): VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD; 45-46 shabu industrial zone; qiaolong district, tangxia; dong guan guangdong,523730 ; CH
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7452888
• MDR Text Key: 106245735
• Report Number: 2050001-2018-00097
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2M8021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/23/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention