MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-30 for LIBERATOR 30 13256988 manufactured by Caire Inc..
[148007665]
The unit has been returned for evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[148007666]
Saturday, (b)(6) 2019, at 7. 40, a patient called and said that there was an involuntary depletion from vessels and stroller was connected while filling. The stroller (sf) remained on the vessel while the vessel emptied. It was agreed that the vessel had to empty itself and she closed the door and ventilated the room. We kept in touch during the evening and eventually it sounded and silenced when the vessel had emptied itself. The last filling before this happened at 15 o'clock i. E. About four hours interval between the fillings. It is always difficult to know what really happens in these situations, but the patient is well familiar with the equipment and filling her stroller according to instruction. She took track of filling time, the nature of the sound and the stroller's content measuring meter to interrupt the filling with its help when the thermos is full. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00035 |
| MDR Report Key | 8656086 |
| Report Source | FOREIGN |
| Date Received | 2019-05-30 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-04-27 |
| Date Mfgr Received | 2019-05-02 |
| Date Added to Maude | 2019-05-30 |
| 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 30 |
| Generic Name | UNIT, LIQUID-OXYGEN, STATIONARY |
| Product Code | BYJ |
| Date Received | 2019-05-30 |
| Returned To Mfg | 2019-05-21 |
| Model Number | 13256988 |
| 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 | 2019-05-30 |