MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-05-23 for SPIRIT 13103105 manufactured by Caire Inc..
[109044287]
The unit was returned to (b)(6) center in (b)(6) and tested. The fault could not be reproduced and was said to be functioning normally. Caire is attempting to have the unit returned to perform their own evaluation. If any more information is discovered, a follow-up mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[109044288]
The patient's wife filled the portable unit via the side fill valve of the base unit. After removing the portable unit from the base unit, liquid oxygen started to flow out of the base unit. Liquid oxygen got onto both hands of his wife. The resulting injuries (2nd degree burns) were treated in a hospital outpatient facility. The patient has been supplied with liquid oxygen products since (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2018-00017 |
| MDR Report Key | 7537531 |
| Report Source | FOREIGN |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-04-14 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-23 |
| 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 | SPIRIT |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2018-05-23 |
| Model Number | 13103105 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 1. Hospitalization | 2018-05-23 |