MAUDE Adverse Event Report: VEGA TECHNOLOGIES INC. DRIVE MEDICAL; NEBULIZER COMPRESSOR

Model Number	6910P-DR
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a portable compressor nebulizer by a distributor, who stated the "unit is sparking at the tubing connector when powering on." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a portable compressor nebulizer by a distributor, who stated the "unit is sparking at the tubing connector when powering on." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: NEBULIZER COMPRESSOR
• Manufacturer (Section D): VEGA TECHNOLOGIES INC.; yangwu district,; dalang town; dongguan, guangdong PA 52378 9; CH 523789
• Manufacturer (Section G): DRIVE DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jillian forster ; yangwu district,; dalang town; dongguan, guangdong, NY 52378-9 ; CH 523789 ; 5169984600
• MDR Report Key: 15808049
• Report Number: 2438477-2022-00112
• Device Sequence Number: 7027733
• Product Code: BTI
• UDI-Device Identifier: 00885304002536
• UDI-Public: 00885304002536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 6910P-DR
• Device Catalogue Number: 6910P-DR
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown