MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-28 for VITAL SIGNS? HEAD POSITIONER 8000HDP manufactured by Vyaire Medical..
| Report Number | 9613793-2020-00009 |
| MDR Report Key | 9771507 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-28 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Street | 602 PARKWAY, GLOBAL PARK BOX 180-3006 |
| Manufacturer City | LA AURORA, 146 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? HEAD POSITIONER |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2020-02-28 |
| Model Number | VITAL SIGNS? HEAD POSITIONER |
| Catalog Number | 8000HDP |
| Lot Number | 49797348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |