MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO QUIET; GENERATOR, OXYGEN, PORTABLE

Model Number 1020014

Device Problem Leak/Splash (1354)

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

The manufacturer received information in relation to a everflo quiet device.The device was serviced by a field service technician.During the evaluation of the device had a sieve bed smell that was replaced for preventative maintenance.The inlet filter was dirty, the manifold assembly was leaking and the shipping box was damaged.

Manufacturer Narrative

H3 other text : device evaluated by field service technician.

• Brand Name: EVERFLO QUIET
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18431183
• MDR Text Key: 331907674
• Report Number: 2518422-2024-00151
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032620
• UDI-Public: 00606959032620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1