MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for INVACARE OXYGEN CONCENTRATOR IVC IRC5P02V manufactured by Invacare Corp..
[181527248]
Oxygen concentrator made a loud pop then started to smoke. The fire dept was called and the equipment was disconnected and removed from the residence by the firemen. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093298 |
| MDR Report Key | 9754091 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-22 |
| Date of Event | 2020-02-02 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-21 |
| Model Number | IVC IRC5P02V |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORP. |
| Manufacturer Address | ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |