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

Model Number 1020010

Device Problems Mechanical Problem (1384); Excessive Heating (4030)

Patient Problems Dizziness (2194); Sore Throat (2396)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of allegation of patient smoking whilst on o2, tubing burnt on everflo intl opi 230v device.Customer also stated that concentrator not working, patient wasn't rousable, and was very drowsy / sore throat and could not stay awake.Currently, the device has not yet returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: EVERFLO INTL OPI 230V
• 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: 18099266
• MDR Text Key: 327707079
• Report Number: 2518422-2023-29584
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male