MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO 120V; GENERATOR, OXYGEN, PORTABLE

Model Number 1020001

Device Problems Failure to Power Up (1476); Temperature Problem (3022)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a everflo 120v opi domestic device's thermal event.The manufacturer received information alleging the outside cover of the unit is hot to the touch.There was no serious patient harm or injury.The patient required no medical intervention.The patient required no medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: EVERFLO 120V
• 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: 18989535
• MDR Text Key: 338740383
• Report Number: 2518422-2024-15303
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1