MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-03-08 for PASSPORT NEBULIZER IRC 1190 IRC 1190 NEBULIZER manufactured by Invacare Corp..
[145958]
Mfr received a report from a claims adjuster alleging the nebulizer caught fire causing damages to the carpeting and surroundings. No injury was reported as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2000-00015 |
| MDR Report Key | 268092 |
| Report Source | 00 |
| Date Received | 2000-03-08 |
| Date of Report | 2000-03-03 |
| Date of Event | 1999-03-01 |
| Date Mfgr Received | 1999-07-01 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 2000-03-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RAE FARROW |
| Manufacturer Street | 899 CLEVELAND ST |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 4403296356 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT NEBULIZER |
| Generic Name | THERAPEUTIC HUMIDIFIER |
| Product Code | JPW |
| Date Received | 2000-03-08 |
| Model Number | IRC 1190 |
| Catalog Number | IRC 1190 NEBULIZER |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 259524 |
| Manufacturer | INVACARE CORP. |
| Manufacturer Address | 899 CLEVELAND STREET ELYRIA OH 44035 US |
| Baseline Brand Name | PASSPORT NEBULIZER |
| Baseline Generic Name | THERAPEUTIC HUMIDIFIER |
| Baseline Model No | IRC 1190 |
| Baseline Catalog No | IRC 1190 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-08 |