MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for CAPTUS 3000 THYROID UPTAKE SYSTEM 5430-0077 manufactured by Capintec, Inc..
[130328490]
On (b)(6) 2018 capintec was informed of an arm failure on a captus 3000 thyroid update system- serial number (b)(4). A component in the spring arm (tension rod) broke causing the arm with the collimator to fall downward. No staff or patient was in the room at the time of the event. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518443-2018-00002 |
| MDR Report Key | 8154548 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-13 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2014-02-27 |
| Date Added to Maude | 2018-12-12 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARY YUSKO |
| Manufacturer Street | CAPINTEC, INC. 7 VREELAND ROAD |
| Manufacturer City | FLORHAM PARK NJ 07932 |
| Manufacturer Country | US |
| Manufacturer Postal | 07932 |
| Manufacturer Phone | 2018259500 |
| Manufacturer G1 | MARY ANNE YUSKO |
| Manufacturer Street | 7 VREELAND ROAD |
| Manufacturer City | FLORHAM PARK NJ 07932 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07932 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTUS 3000 THYROID UPTAKE SYSTEM |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2018-12-12 |
| Model Number | 5430-0077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPINTEC, INC. |
| Manufacturer Address | 7 VREELAND ROAD FLORHAM PARK NJ 07932 US 07932 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |