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

Model Number 1020001

Device Problem Leak/Splash (1354)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The manufacturer received information in relation to a everflo device.The device was serviced by a field service technician.During the evaluation of the device had sieve beds with low o2, solenoid not switching, regulator broken, power cord chewed up and the manifold leaking.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: EVERFLO
• 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: 18440244
• MDR Text Key: 331874833
• Report Number: 2518422-2024-00452
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: 00606959022041
• 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: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1