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

Model Number 1020009

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

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

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : analysis by third-party.

Event Description

The manufacturer became aware of an allegation of everflo intl opi that the patient alleges that the device is defective.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 power code is defective, the led not working and low 02, noise, fuse, manifold, tubing kit, sieve kit, and inlet filter.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: EVERFLO INTL OPI
• 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: 18570614
• MDR Text Key: 333564446
• Report Number: 2518422-2024-04011
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032583
• UDI-Public: 00606959032583
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020009
• Device Catalogue Number: 1020009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1