MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-22 for SC900DLX IHSC900DLX manufactured by Invacare Florida.
| Report Number | 1031452-2019-00080 |
| MDR Report Key | 9364217 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-22 |
| Date of Report | 2019-10-31 |
| Date Mfgr Received | 2019-10-31 |
| Date Added to Maude | 2019-11-22 |
| 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 | 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 | SC900DLX |
| Generic Name | BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE |
| Product Code | LLI |
| Date Received | 2019-11-22 |
| Model Number | IHSC900DLX |
| Catalog Number | IHSC900DLX |
| Lot Number | NA |
| 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 | 2019-11-22 |