MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-04-07 for PROGENY PREVA PE7017 manufactured by Midmark Corporation.
[1644075]
A service technician from a dealer reported that a preva intra-oral x-ray unit, serial number (b) (6), supplied a "mild electrical shock" to an operator. The service engineer measured 7v and 1300ma from the metal chassis of the machine to earth ground. Upon investigation, the service engineer found to open or poor connections between the machine and earth ground.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2010-00002 |
| MDR Report Key | 1657243 |
| Report Source | 08 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2009-02-22 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2010-05-25 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA BARTAKOVICS |
| Manufacturer Street | 675 HEATHROW DR. |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 8474159763 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGENY PREVA |
| Product Code | MUH |
| Date Received | 2010-04-07 |
| Returned To Mfg | 2010-03-22 |
| Model Number | PREVA |
| Catalog Number | PE7017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-04-07 |