MAUDE Adverse Event Report: DICKSON ASIA/VEGA, NEB-ROS ROSCOE MINI NEB COMPRESSOR; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AG-MNEB

Device Problem Device Handling Problem (3265)

Patient Problem Electrocution (1827)

Event Date 04/17/2014

Event Type  No Answer Provided  

Event Description

Mother reported to customer that her (b)(6) son was electrocuted by his nebulizer.Child was sitting on her lap receiving his breathing treatment and he reached to touch it and where the cord connects to the machine, it sparked and the machine turned off.Child's fingers had a burn from the spark and were black and he immediately said "ouch ouch arm arm".He showed mother the opposite arm that was shocked.Mother was concerned and called his pediatrician, they wanted to see him immediately.They checked him and said the electrocution went through one arm and out the other.Everything appeared normal, breathing was fine, heart sounded normal, he didn't feel like we needed to any other tests.Ref mfr#: 3004874794-2015-00001.

• Brand Name: NEB-ROS ROSCOE MINI NEB COMPRESSOR
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): DICKSON ASIA/VEGA,; flat b, 18th floor; block 19, hoi yat mansion reviera garden; tsuen wan, n.t. ; HK
• MDR Report Key: 4729578
• MDR Text Key: 5748720
• Report Number: 3005182235-2015-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AG-MNEB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/19/2014
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 04/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 2 YR