MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for COMPANION 1000 B-775532-00 manufactured by Caire Inc..
[188210835]
Three attempts have been made to have the device returned for evaluation. No response has been received about the unit.
Patient Sequence No: 1, Text Type: N, H10
[188210836]
This report was originally submitted on 11/15/2017, and is being resubmitted on 3/20/2020 as the original submission failed to go through. The strap broke on a portable oxygen tank while in transport.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2017-00057 |
| MDR Report Key | 9862399 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-10-16 |
| Device Manufacturer Date | 2011-04-13 |
| Date Added to Maude | 2020-03-20 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | COMPANION 1000 |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2020-03-20 |
| Model Number | B-775532-00 |
| 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 | 2020-03-20 |