MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-25 for QS820 MANUAL BED IH820 manufactured by Invacare Florida Operations.
[45990805]
Mdr is being submitted as a result of a retrospective complaint review.
Patient Sequence No: 1, Text Type: N, H10
[45990806]
The weld at the bottom of the leg frame has broke.
Patient Sequence No: 1, Text Type: D, B5
[46812487]
Mdr is being submitted as a result of a retrospective complaint review. Information updated to reflect the correct complaint awareness date, initial reporter, and device model number.
Patient Sequence No: 1, Text Type: N, H10
[46812488]
The weld at the bottom of the leg frame has broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2016-02362 |
| MDR Report Key | 5679006 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-25 |
| Date of Report | 2011-11-21 |
| Date Mfgr Received | 2011-11-21 |
| Date Added to Maude | 2016-05-25 |
| 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 CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA OPERATIONS |
| 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 | QS820 MANUAL BED |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2016-05-25 |
| Model Number | IH820 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA OPERATIONS |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-25 |