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

Model Number 1020014

Device Problems Mechanical Problem (1384); Power Problem (3010)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of everflo quiet that the patient alleges that the device is alarming.A device was returned to a third-party service center.During the evaluation of the device, they found out that the complaint was confirmed, the sieve beds blown, the solenoid was intermittent, the regulator was damaged, pca board has non-stop alarming, flow meter was cracked, and power cord was smashed.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : analysis by third-party.

• 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: 18530827
• MDR Text Key: 333164002
• Report Number: 2518422-2024-03093
• 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: 01/17/2024
• 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: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1