MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-05-15 for SPIRIT 20606204 manufactured by Caire Inc..
[108346835]
Unit has not been returned, if the unit is returned for evaluation and any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108346836]
On (b)(6) in the afternoon, customer contacted (b)(6) customer business centre (cbc). Customer told to pharmacist, that he was filling the portable device from the homelox vessel the previous day, (b)(6) (between 13 and 14 o'clock). When filling was almost finished, customer got a burn to his middle finger as the portable device blew the oxygen out. Customer stopped the leakage by attaching the portable back to homelox-vessel. Service center (b)(4) tested the device. A minor leak was identified and fixed. Unit should now function properly according to (b)(4)'s technicians. Chart is attempting to have the unit returned to perform it's own evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2018-00015 |
| MDR Report Key | 7517155 |
| Report Source | FOREIGN |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-17 |
| Date Added to Maude | 2018-05-15 |
| 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 | 2018-05-15 |
| Model Number | 20606204 |
| 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 | 2018-05-15 |