MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-10 for LIBERATOR 45 13262261 manufactured by Caire Inc..
[176989339]
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.
Patient Sequence No: 1, Text Type: N, H10
[176989340]
Praxair received a call from the nurse. They noticed that the liberator was freezing, and the oxygen cannula exploded due to high pressure. The cannula had liquid oxygen, causing second degree burns to the patient's throat and face. The patient was transported to the hospital for emergency attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2020-00001 |
| MDR Report Key | 9578328 |
| Report Source | FOREIGN |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2019-12-12 |
| Date Added to Maude | 2020-01-10 |
| 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 | LIBERATOR 45 |
| Generic Name | UNIT, LIQUID OXYGEN, STATIONARY |
| Product Code | BYJ |
| Date Received | 2020-01-10 |
| Model Number | 13262261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2020-01-10 |