MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO INTL OPI 230V S.AFRICA; GENERATOR, OXYGEN, PORTABLE

Model Number 1020009

Device Problem Failure to Power Up (1476)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device was evaluated by a third-party service center.

Event Description

The manufacturer received information from a third-party service center alleging an everflo intl opi 230v s.Africa device is dead due to the ac power cord failure.There was no report of patient harm or injury.During the device evaluation at a third-party service center, the power cord was replaced, and the compressor plug kit.There was no report of exposed or burnt wires.Product labeling states", do not use the oxygen concentrator if the plug or power cord is damaged.Do not use extension cords or electrical adapters." 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 230V S.AFRICA
• 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: 18197065
• MDR Text Key: 328943203
• Report Number: 2518422-2023-31398
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020009
• Device Catalogue Number: 1020009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1