MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-29 for CAPTUS 3000 5430-0077 manufactured by Capintec, Inc..
[37728200]
Capintec has contracted with two outside firms, hamel engineering sciences, inc. And industrial testing laboratory services, llc , for static, dynamic and metallurgical studies. To date, the reports have been inconclusive in determining root cause. Additional testing is in process.
Patient Sequence No: 1, Text Type: N, H10
[37728201]
While performing routine quality assurance testing on the capinte captus 3000 thyroid uptake system, a component in the spring arm (tension rod) broke causing the arm with the collimator to fall downward to its lowest point of travel, which is approximately 25 inches from the ground. The collimator and arm weigh 45 pounds, and could cause an injury if it hits a patient or operator. In this case, no patient was involved, and no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518443-2016-00001 |
| MDR Report Key | 5398253 |
| Date Received | 2016-01-29 |
| Date Mfgr Received | 2015-12-29 |
| Device Manufacturer Date | 2011-12-13 |
| Date Added to Maude | 2016-01-29 |
| 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 | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer Phone | 4129631988 |
| Manufacturer G1 | 2518443 |
| Manufacturer Street | 620 ALPHA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTUS 3000 |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2016-01-29 |
| Returned To Mfg | 2016-01-07 |
| Model Number | CAPTUS 3000 |
| Catalog Number | 5430-0077 |
| Lot Number | NOT APPLICABLE |
| Operator | NUCLEAR MEDICINE TECHNOLOGIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPINTEC, INC. |
| Manufacturer Address | 620 ALPHA DRIVE PITTSBURGH PA 15238 US 15238 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-29 |