MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-03 for COMPANION C1000T B-700883-00 manufactured by Caire Inc..
[183306015]
The unit has been returned for an evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183306016]
We have had a complaint from a liquid oxygen user as he has sustained facial burns whilst using liquid oxygen. We have been sent photos by the patient of his injuries and there is a very obvious marking around his face, neck and ears which coincide with where the cannula would be on his face. The patient has also got burns in his nasal area. We have obtained details from the patient in regards to how the oxygen was being used and he has stated that he filled the flask from the oxygen dewer and then around 30 minutes after that went to walk his dog. Whilst walking his dog he felt a surge in the flow and said that it felt like the liquid oxygen was coming out of the flask. The patient then went home and it was at this point that the cannula was found to have been frozen to his nose, and his wife helped to remove the cannula. The patient advised that the cannula was brittle and snapped when it was removed. The patients face swelled and he had to seek medical attention for his injuries. The a&e department and the patient gp have both confirmed that the injuries were as a result of cold burns/ frostbite. As a company we have not had an incident like this before, so have explored all areas that we can to date. The patient is not a smoker, therefore not smoking related and also the injuries are not consistent of those which would be smoking related. We have also quarantined and tested the equipment, but no obvious faults could be found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00056 |
| MDR Report Key | 9548569 |
| Report Source | FOREIGN |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2019-12-06 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEAL MALOY |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal | 30107 |
| Manufacturer Phone | 7707217700 |
| Manufacturer G1 | CAIRE INC. |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPANION C1000T |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2019-12-20 |
| Model Number | B-700883-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAIRE INC. |
| Manufacturer Address | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US 30107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-03 |