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..
[137434153]
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
[137434154]
Complaint about emptying home lox vessel. Incident occurred (b)(6) 2018. Filling from home lox vessel to stroller has been done as usual. No problem to loosen the stroller from the vessel. No "overfilling" has occurred. Directly after filling, the vessel begins to spray thick smoke and leak blue liquid from qdv-valve. The vessel was moved and placed closed to the patio door. After approx. 10 minutes the vessel was empty. The patient has used the product longer than one week and two times per day, has used several vessel during this time. The customer has been informed that it's very important that the odv-valve is dry when filling to the stroller. No suspicion of any user-error. No harm on the patient or other person.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00009 |
| MDR Report Key | 8348619 |
| Report Source | FOREIGN |
| Date Received | 2019-02-18 |
| Date of Report | 2019-07-24 |
| Date of Event | 2018-09-17 |
| 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 |