MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-29 for ANALYZER, GAS, OXYGEN, GASEOUS-PHASE IRC10LX02 manufactured by Invacare.
[1880825]
The unit had a burning smell when the dealer plugged it in the first time. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[2722821]
The unit had a burning smell when the dealer plugged it in for the first time. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[9176934]
No injury reported. Device was new. Nature of complaint suggests a new product, and the new compressor will have a slight odor as it wears in. This odor is normal and will dissipate as the compressor wears in. Device is thermally protected. Manufacturer is attempting to obtain the product for inspection. Filing solely on the allegation of a burning smell, malfunction is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[9910029]
No injury reported. Device was new. Nature of complaint suggests a new product, and the new compressor will have a slight odor as it wears in. This odor is normal and will dissipate as the compressor wears in. Device is thermally protected. Manufacturer is attempting to obtain the product for inspection. Filing solely on the allegation of a burning smell, malfunction is not confirmed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2011-00144 |
| MDR Report Key | 2043706 |
| Report Source | 08 |
| Date Received | 2011-03-29 |
| Date of Report | 2011-03-29 |
| Date of Event | 2011-03-08 |
| Date Mfgr Received | 2011-03-09 |
| Date Added to Maude | 2011-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BOB ROGERS |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA OPERATIONS |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Generic Name | 868.1720 |
| Product Code | CCL |
| Date Received | 2011-03-29 |
| Model Number | IRC10LX02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE |
| Manufacturer Address | ONE INVACARE WAY ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-29 |