MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for RC ULTRA HI-LO 850 BED RCUHLB850BED manufactured by Camtec.
| Report Number | 3009402404-2019-00066 |
| MDR Report Key | 9145362 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-09-14 |
| Date Mfgr Received | 2019-09-16 |
| Date Added to Maude | 2019-10-02 |
| 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 HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | CAMTEC |
| Manufacturer Street | 1959 CHURCH CREEK RD |
| Manufacturer City | CAMBRIDGE MD 21613 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RC ULTRA HI-LO 850 BED |
| Generic Name | BARIATRIC PATIENT ELECTRIC BED |
| Product Code | OSI |
| Date Received | 2019-10-02 |
| Model Number | RCUHLB850BED |
| Catalog Number | RCUHLB850BED |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAMTEC |
| Manufacturer Address | 1959 CHURCH CREEK RD CAMBRIDGE MD 21613 US 21613 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-02 |