MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for VETPRO VETPRO DC 2.0 DCV7-G2A/H manufactured by Midmark Corporation.
[126553095]
On (b)(6) 2018 it was reported to midmark by a dealer technician that an x-ray unit (vetpro dc 2. 0, 76" reach, w/two stud mount; serial number (b)(4)) separated from the wall in which it was secured. There were no injuries or contact with any person. The unit detached from the wall when the facility was closed and discovered in the morning by facility staff, as reported by the complainant. The unit mounting was visually inspected at the user facility by the technician and photographs were received by midmark technical services. The technician, after inspection of the mounting apparatus concluded that the bolts were not properly installed by the installation technician at the time of unit install. The lag bolts, provided by midmark, were installed into the wall and did not correctly connect with the stud causing the machine to not be securely attached to the wall. The original hardware provided with the x-ray system was observed to be present but the lag screws were mounted off-center on the stud or completely missed the stud. It is unknown if the installation manual was used at the time of initial installation. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-2018-00004 |
| MDR Report Key | 8018741 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-10-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADAM FORESMAN |
| Manufacturer Street | 675 HEATHROW DRIVE |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2242204329 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VETPRO |
| Generic Name | VETPRO DC |
| Product Code | EAP |
| Date Received | 2018-10-30 |
| Model Number | VETPRO DC 2.0 |
| Catalog Number | DCV7-G2A/H |
| Device Availability | N |
| 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 | 2018-10-30 |