MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO; PHILIPS CPAP DEVICE

Model Number 1020000

Device Problem Fire (1245)

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

Event Date 06/02/2023

Event Type  Death  

Event Description

The manufacturer was contacted in reference to an everflo oxygen concentrator.The manufacturer received information alleging that the home was severely damaged in-house fire and the patient passed away.Everflo oxygen concentrator was in the area of where the fire started.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
• Type of Device: PHILIPS CPAP DEVICE
• 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: 18138855
• MDR Text Key: 328134251
• Report Number: 2518422-2023-30234
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• 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,Consumer
• 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: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death