MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-02 for CAPTUS 4000 CAPTUS 4000E 5430-30152 manufactured by Capintec, Inc..
[139570600]
On (b)(6) 2019 capintec was informed that the collimator fell off a captus 4000 thyroid update system- serial number (b)(4). Technologist just completed qc on the system. She was performing capsule counts when the collimator fell off. No injuries occurred. Service personnel replaced the collimator assembly on site. User was instructed to return failed parts for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518443-2019-00001 |
| MDR Report Key | 8384799 |
| Date Received | 2019-03-02 |
| Date of Report | 2019-03-02 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2016-07-19 |
| Date Added to Maude | 2019-03-02 |
| 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 | MS MARY 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTUS 4000 |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2019-03-02 |
| Returned To Mfg | 2019-02-26 |
| Model Number | CAPTUS 4000E |
| Catalog Number | 5430-30152 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-02 |