MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE DRIVE DEVILBISS TRAVELER; PORTABLE COMPRESSOR/NEBULIZER

Model Number 6910P-DR

Device Problem Device Handling Problem (3265)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Devilbiss healthcare was notified on 03/25/2022 of a complaint involving a 6910p-dr portable compact traveler nebulizer.The complainant noted "received in bad condition with the box ripped open/opened up".While operating the unit, "it gets very hot to the touch".No medical attention was sought and no treatment was received.Devilbiss healthcare is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update as soon as additional information becomes available.

• Brand Name: DRIVE DEVILBISS TRAVELER
• Type of Device: PORTABLE COMPRESSOR/NEBULIZER
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 99 seaview blvd; port washington NY 11050
• Manufacturer (Section G): DRIVE DEVILBISS HEALTHCARE; 99 seaview blvd; port washington NY 11050
• Manufacturer Contact: lenora patrick ; 99 seaview blvd; port washington, NY 11050 ; 5169984600
• MDR Report Key: 14166816
• MDR Text Key: 298985954
• Report Number: 2515872-2022-00060
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6910P-DR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 71 KG