MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-23 for EUREKA COLLIMATOR LINEAR IV 70-75000-6 manufactured by Midmark Corporation.
[2114167]
An onsite technician from the end user reported that the mechanical structure of a linear iv collimator unit, serial number (b)(4), separated from its mount. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2011-00002 |
| MDR Report Key | 2138105 |
| Report Source | 06 |
| Date Received | 2011-06-23 |
| Date of Report | 2011-06-20 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Device Manufacturer Date | 2000-10-01 |
| Date Added to Maude | 2011-07-26 |
| 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 | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LISA BARTAKOVICS |
| Manufacturer Street | 675 HEATHROW DR. |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 8474159763 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 675 HEATHROW DR. |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60069 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUREKA COLLIMATOR |
| Generic Name | COLLIMATOR, AUTOMATIC, RADIOGRAPHIC |
| Product Code | IZW |
| Date Received | 2011-06-23 |
| Returned To Mfg | 2011-05-27 |
| Model Number | LINEAR IV |
| Catalog Number | 70-75000-6 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 675 HEATHROW DR. LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-23 |