MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-10-23 for LIBERATOR 13256988 manufactured by Caire Inc..
[125613388]
The unit has not been returned for evaluation. If any new information is discovered, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[125613429]
Filling from home lox vessel to stroller has been done as usual. When the stroller takes away from the vessel the qdv valve does not close and then the vessel starts to drain. The previous filling was at 3pm the day before, so 18 hours between these two fillings. The customer has used the product from (b)(6) 2015 and from (b)(6) 2016 has used the side-fill vessels. No suspicion of any user-error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2018-00049 |
| MDR Report Key | 7996834 |
| Report Source | FOREIGN |
| Date Received | 2018-10-23 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-23 |
| 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 |
| Generic Name | UNIT, LIQUID-OXYGEN, STATIONARY |
| Product Code | BYJ |
| Date Received | 2018-10-23 |
| Returned To Mfg | 2018-11-05 |
| 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 | 2018-10-23 |