MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-18 for PROGENY VANTAGE VANTAGE WITH CEPH EXTENSION V5000C manufactured by Midmark Corporation.
[3687443]
A radiologic technologist from a dental imaging center reported to a midmark sales representative that during the process of positioning a patient, a vantage panoramic x-ray unit, serial number (b)(4), would continue moving down after the "down" button on the patient table was released. The radiologic technologist removed the patient from the machine. There was only one occurrence and the machine performed normally afterwards. The midmark sales representative spoke to the radiologic technologist and confirmed there was no injury.
Patient Sequence No: 1, Text Type: D, B5
[10893305]
The unit is equipped with an emergency stop switch. The user manual explains that "depressing the button will immediately halt all motor movement". A midmark sales representative performed an on-site investigation and confirmed that the vertical movement switches allowed the column to move up, down and stop upon command. The emergency stop switch was confirmed to function as intended. The vertical movement switch and the associated cable were replaced and returned to midmark for further analysis. The alleged failure could not be reproduced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423380-2013-00003 |
| MDR Report Key | 3234347 |
| Report Source | 07 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-06-19 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2013-05-21 |
| Date Added to Maude | 2013-10-16 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MIKE COYLE |
| Manufacturer Street | 675 HEATHROW DR. |
| Manufacturer City | LINCOLNSHIRE 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 8474159800 |
| 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 | PROGENY VANTAGE |
| Generic Name | SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITAL |
| Product Code | MUH |
| Date Received | 2013-07-18 |
| Returned To Mfg | 2013-07-11 |
| Model Number | VANTAGE WITH CEPH EXTENSION |
| Catalog Number | V5000C |
| Operator | RADIOLOGIC TECHNOLOGIST |
| 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 | 2013-07-18 |