MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-20 for NEWLIFE INTENSITY 10 AS099-101 manufactured by Caire Inc..
[188213641]
Device has been returned for evaluation. If any new information is discovered, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188213642]
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. Unit reported to be having electrical problem and smells like it's burning. No smoke, just smells hot. There were no injuries to patients or the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2017-00039 |
| MDR Report Key | 9862600 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2018-06-25 |
| Date Mfgr Received | 2017-10-16 |
| Device Manufacturer Date | 2017-09-11 |
| 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 |
| 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 | NEWLIFE INTENSITY 10 |
| Generic Name | CONCENTRATOR, OXYGEN, STATIONARY |
| Product Code | CAW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2017-11-08 |
| Model Number | AS099-101 |
| 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 | 2020-03-20 |