MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1020006

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted about one of their everflo oxygen concentrator devices.Per the rwo, the device is experiencing low fi02.There was no clinical or medical intervention specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: EVERFLO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 18487734
• MDR Text Key: 332901861
• Report Number: 2518422-2024-01747
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959032552
• UDI-Public: 00606959032552
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1