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

Model Number 1020000

Device Problems Shipping Damage or Problem (1570); Defective Component (2292)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : analysis by 3rd party.

Event Description

The manufacturer became aware of an allegation of everflo dom that the patient alleges that the shipping box is damaged.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 device power cord is damaged.P-m was replaced.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 DOM
• 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: 18975348
• MDR Text Key: 338600539
• Report Number: 2518422-2024-14529
• Device Sequence Number: 1
• Product Code: CAW
• 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,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: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1