MAUDE Adverse Event Report: CAIRE INC. VISIONAIRE 5; CONCENTRATOR, OXYGEN, STATIONARY

Model Number	AS098-5
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.Caire customer service has requested the unit be returned to caire's langenfeld, germany facility for evaluation.A follow up report will be submitted with the results of the investigation if the unit becomes available for evaluation.
Event or Problem Description
The patient forgot to stop the concentrator before lighting a cigarette.He was burnt at the nose, cheek and left hand.The doctor advised to use a healing cream.
Additional Manufacturer Narrative
Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.The unit was returned to caire's langenfeld, germany facility for evaluation.During the investigation, there was no sign of unit dysfunction.Tubing had a slight yellow tint along with the compressor filters, which is common in the home of smoker.Other than discoloration, the unit had no visible damage.Functional testing revealed low purity at 5 lpm, but the unit alarmed correctly.The adverse event description states that the patient was smoking while the unit was operating.No smoking warnings were reviewed and deemed adequate in the course of the investigation."no smoking" symbols (reg# p002) are affixed to the face of the unit and "no smoking" warnings are included in ifu mn238 as follows: warning: smoking while using oxygen is the number one cause of fire injuries and related deaths.You must follow these safety warnings: warning: do not allow smoking, candles, or open flames in the same room with the device or the oxygen-carrying accessories.Warning: smoking while wearing an oxygen cannula can cause facial burns and possibly result in death.Warning: removing the cannula and placing it on clothing, bedding, sofas, or other cushion material will cause a flash fire when exposed to a cigarette, heat source, spark or open flame.Warning: "no smoking - oxygen in use" signs must be prominently displayed in the home, or where oxygen is in use.Users and their caregivers must be informed about the dangers of smoking in the presence of, or while using,medical oxygen.The visionaire risk assessment - mdd v2 usability analysis includes the following: line fire-4: use error, user smokes or uses an open flame near the device.Effect/harm, oxygen may accelerate nearby fire hazard, 3rd degree burn.Line fire-5: use error, user smokes near the device.Effect/harm, smoke damages the internals of the device, rendering low oxygen purity, temporary respiratory distress without long term effects.The risk file was deemed adequate without updates.No further investigation is required.This issue will be monitored for trending and included in post market surveillance review and periodic safety update reports.

• Brand Name: VISIONAIRE 5
• Common Device Name: CONCENTRATOR, OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: pamela netzel ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7169499810
• MDR Report Key: 16478974
• Report Number: 3004972304-2023-00004
• Device Sequence Number: 13753827
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K872534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AS098-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male