MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-02-18 for LIBERATOR 30 13258799 manufactured by Caire Inc..
[137434859]
The unit has been returned for evaluation. If any new information is discovered, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[137434861]
The customer received 2 x 30 l on 17/8. The flow is 2l / min. Started on the last vessel on thursday, 24/8. Now only 2 dots remain. The customer is very worried that it will not suffice on thursday when he gets a new living. Suspicious leakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00011 |
| MDR Report Key | 8348657 |
| Report Source | FOREIGN |
| Date Received | 2019-02-18 |
| Date of Report | 2019-07-24 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2019-01-20 |
| Date Added to Maude | 2019-02-18 |
| 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 | 2019-02-18 |
| Returned To Mfg | 2019-02-15 |
| Model Number | 13258799 |
| 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 | 2019-02-18 |