MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-03-01 for LIBERATOR 30 13256929 manufactured by Caire Inc..
[137931455]
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
[137931456]
Incident occurred (b)(6) 2019 at 23:20. An unintended depletion of the home lox vessel occurred. The home lox vessel was delivered (b)(6). Filling from home lox vessel to stroller was performed at 18:00 (b)(6). It has been done as usual but after filling there was a whining sound from the vessel. No "overfilling" has occurred, the patient interrupted the filling when the sound was changing or after approximately one minute. The patient perceives that the sound decreases and after 30 minutes from filling the patient leaves the room. When the patient returns to the room the home lox vessel was empty and the vessel was "very icy". Before filling the patient has wiped the df valve. The patient fills the stroller at most once a day. No injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00013 |
| MDR Report Key | 8383905 |
| Report Source | FOREIGN |
| Date Received | 2019-03-01 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-02-02 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-03-01 |
| 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 | 2019-03-01 |
| Returned To Mfg | 2019-02-19 |
| Model Number | 13256929 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-01 |