MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-04-25 for LIBERATOR 45 14454994 manufactured by Caire Inc..
[106566471]
Unit is in the process of being returned for evaluation by manufacturer. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[106566472]
After filling in the portable unit from the top and taking the unit away from the basis unit, liquid oxygen spilled from the filling connector. Liquid oxygen ended up on the patient's left hand's thumb, and ever since the patient has had a numb feeling in her thumb. Moreover, the liquid oxygen ended up on the wall, the sideboard and the carpet. Unit was tested at (b)(6) and the fault could not be reproduced. After talking with the user, it was found out that there is a possibility the connectors of the units were not wiped before filling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2018-00009 |
| MDR Report Key | 7462626 |
| Report Source | FOREIGN |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-03-23 |
| Date Added to Maude | 2018-04-25 |
| 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 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 | LIBERATOR 45 |
| Generic Name | UNIT, LIQUID OXYGEN, STATIONARY |
| Product Code | BYJ |
| Date Received | 2018-04-25 |
| Model Number | 14454994 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-04-25 |