MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-16 for LIBERATOR 30 13256988 manufactured by Caire Inc..
[145669610]
"pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803. 16, neither this report nor any information submitted herein constitutes an admission by caire inc. That the device stated in this report, caire inc. , or caire inc. 's employees, caused or contributed to the reportable event stated herein". The unit is being returned for evaluation. If any new information is discovered, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145669611]
Incident occurred (b)(6) 2019 at 08. 15. An involuntary depletion of the home lox vessel occurred. The patient docks the stroller on the vessel, opens the filling arm, keeps track of time, filling noise and the content meter during filling. Just before it is full, the patient heard an unfamiliar whining sound from the vessel and at the same time there was "liquid condensation" from both the area around the qdv valve and also the stroller's filling arm. The patient got scared but still had the presence of mind and closes stroller's refill arm leaving it on the vessel and left the room - the involuntary depletion occurred. The home lox vessel was last filled the afternoon before, (b)(6), both qdv valves were dry and the stroller was empty. Patient also described stroller was tipped over after yesterday's filling and that the flow selector went sluggish to twist and that the filling arm became "slanted" and difficult to get in position (this patient discovered today at the filling). It hadn't leaked anything in connection with it being tipped. Not sure what this caused for injury. The patient has been running his lox treatment since (b)(6) 2019. Experience of patient is as careful and well-versed in function and operation. The patient is calm. No harm on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00024 |
| MDR Report Key | 8521139 |
| Report Source | FOREIGN |
| Date Received | 2019-04-16 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-04-16 |
| 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 | 2019-04-16 |
| Returned To Mfg | 2019-04-02 |
| 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 | 2019-04-16 |