MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for PERFECTO2 V WITH SENSOR 9153650799 NA:IRC5PO2V IRC5PO2V manufactured by Invacare Florida.
[185201546]
This report is being filed in an abundance of caution. The dealer stated to the best of their knowledge the concentrator was not the cause of any injury or damage. The concentrator has been recovered by the dealer and is currently in quarantine. The dealer will not return the concentrator at this time. The user manual part #1193322-a-04 page 8 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. To avoid fire, death, injury or damage: do not smoke while using this device. Do not use near open flame or ignition sources. Do not use any lubricants on concentrator unless recommended by invacare. No smoking signs should be prominently displayed. Avoid creation of any spark near oxygen equipment. This includes sparks from static electricity created by any type of friction. Keep all matches, lighted cigarettes, electronic cigarettes or other sources of ignition out of the room in which this concentrator is located and away from where oxygen is being delivered. Keep the oxygen tubing, cord, and concentrator out from under such items as blankets, bed coverings, chair cushions, clothing, and away from heated or hot surfaces including space heaters, stoves, and similar electrical appliances. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185201547]
Hospice reported to the dealer, that the patient was smoking while using the irc5po2v oxygen concentrator, caught himself on fire and expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00007 |
| MDR Report Key | 9888180 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2020-03-27 |
| 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. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| 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 | 2020-03-27 |
| Model Number | NA:IRC5PO2V |
| Catalog Number | IRC5PO2V |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-03-27 |