MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-18 for FREESTYLE 3 AS095-2 manufactured by Caire Inc..
[188211971]
The incident was reported by a primary care professional. A (b)(6) year old woman with home oxygen was assessed for dyspnea. She was assessed the previous day for the same reason by home notice. The patient stated she was not able to breathe. It was reported that the patient had the following symptoms: oxygen saturation: 40%, blood pressure: 80/40, chill hands, sweating, decreased level of consciousness. The patient was sent to the emergency room, received treatment, and recovered from the stated symptoms. The staff identified the patient's portable oxygen device as a possible problem. It had a 75% charged battery. The patient's caregiver stated that the device was set to 2 lpm, but the patient continually changed it to 3 lpm insufficiently.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2020-00009 |
| MDR Report Key | 9851269 |
| Report Source | FOREIGN |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 Phone | 7707217700 |
| 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 | FREESTYLE 3 |
| Generic Name | OXYGEN CONCENTRATOR, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-03-18 |
| Model Number | AS095-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-18 |