MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-08 for PROGENY VANTAGE 60-A0001 V5000 manufactured by Midmark Corporation.
[4364971]
A dental assistant of a dental office reported to a dealer field technician who then reported to midmark that the column of a vantage x-ray system, serial number (b)(4), was observed to move up without the movement control button being pressed. The dealer technician inspected the machine and reported that he double tapped on the left membrane switch to make the unit move down, and the unit kept moving downward without the membrane switch being pressed. The machine has a movement control membrane switch on both sides of the patient table. The malfunction only happened when the membrane switch on the left hand side was used. Midmark confirmed with the dental office that there was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2014-00003 |
| MDR Report Key | 3800655 |
| Report Source | 08 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2014-04-09 |
| Device Manufacturer Date | 2011-05-24 |
| Date Added to Maude | 2014-06-25 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PENG LIN |
| Manufacturer Street | 675 HEATHROW DRIVE |
| Manufacturer City | LINCOLNSHIRE IL 60065 |
| Manufacturer Country | US |
| Manufacturer Postal | 60065 |
| Manufacturer Phone | 8474159787 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 675 HEATHROW DRIVE |
| 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 | 2014-05-08 |
| Model Number | 60-A0001 |
| Catalog Number | V5000 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US 60069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |