MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-03 for PERFECTO2 V WITH SENSOR 9153650799 NA:IRC5PO2V IRC5PO2V manufactured by Invacare Florida.
[181781122]
This record is being filed in an abundance of caution. At the time of this filing, no malfunctions or deficiencies have been alleged. The dealer said they have the unit in quarantine, and have no plans to return the unit. On page 9 of the user manual part #1193322-b, it states: danger! Risk of death, injury or damage from fire textiles, oil or petroleum substances, grease, greasy substances and other combustibles are easily ignited and burn with great intensity in oxygen enriched air and when in contact with oxygen under pressure. Smoking during oxygen therapy is dangerous and is likely to result in burns or death. To avoid fire, death, injury or damage: do not smoke while using this device. Do not use near open flame or ignition sources. No smoking signs should be prominently displayed. Keep all open flames, matches, lighted cigarettes, electronic cigarettes or other sources of ignition at least 10 ft (3 m) away from this concentrator or any oxygen carrying accessories such as cannulas or tanks. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[181781123]
Invacare received a communication from the dealer that stated, they were notified that a hospice patient was smoking while using an oxygen concentrator and was burned. The patient was airlifted to the hospital and passed away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00005 |
| MDR Report Key | 9779877 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2020-03-03 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA |
| 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 | PERFECTO2 V WITH SENSOR 9153650799 |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-03-03 |
| Model Number | NA:IRC5PO2V |
| Catalog Number | IRC5PO2V |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2020-03-03 |