MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for CAPTUS 3000 THYROID UPTAKE SYSTEM 5430-0077 manufactured by Capintec, Inc..
[126358826]
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. The patient was seated in a chair and the technologist was preparing to perform a thyroid uptake procedure on the patient. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518443-2018-00001 |
| MDR Report Key | 8026941 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2011-09-22 |
| Date Added to Maude | 2018-10-31 |
| 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 ANNE YUSKO |
| Manufacturer Street | 7 VREELAND ROAD |
| Manufacturer City | FLORHAM PARK NJ 07932 |
| Manufacturer Country | US |
| Manufacturer Postal | 07932 |
| Manufacturer Phone | 2018259500 |
| Manufacturer G1 | CAPINTEC, INC. |
| 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 |
| Removal Correction Number | 2518443-11/01/18-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTUS 3000 THYROID UPTAKE SYSTEM |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-10-22 |
| Model Number | 5430-0077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-31 |