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 13256988 manufactured by Caire Inc..
[137434338]
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
[137434339]
Complaint about emptying home lox vessel. After filling of the stroller the qdv valve could not close and the home lox vessel was emptying. The vessel is sent to (b)(4) but the stroller is left at patient's home. The patient is not new and has used this product before. The same event has happened for the same patient approx. 3 weeks earlier. The patient has used this product since (b)(6) 2015 and has changed to side fill vessel from (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00008 |
| MDR Report Key | 8348591 |
| Report Source | FOREIGN |
| Date Received | 2019-02-18 |
| Date of Report | 2019-07-24 |
| Date of Event | 2018-10-09 |
| 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 | 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 | 2019-02-18 |