MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-09-29 for DICOM BOX (AAM CA) 100-00638-00 manufactured by Nai Tech Products, Inc..
[950373]
A distributor field service engineer reported that sparks were generated when he moved the power cord of the device. A review onsite by nai tech products personnel revealed that the power cord of the device had been improperly wired into the internal power supply terminal block of the c-arm. The improper grounding of the device presented a potential electrical shock hazard. The device had been sold as an accessory to the c-arm as an after sale product. The device was installed by nai tech products personnel in early 2008 and functioned properly for eight months without any incident despite this electrical condition. Operation of the device is through a low voltage hand controller which limited any direct contact to the device. Please note that there was no defect in the actual device, it was an installation wiring error by our service technician.
Patient Sequence No: 1, Text Type: D, B5
[8097577]
In regards to remedial action, we are sending out a notice and replacement power cord to similar installations done by nai tech products personnel. We will then send a technician to each such installation and inspect the wiring to ensure all devices are wired correctly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938727-2008-00001 |
| MDR Report Key | 1184592 |
| Report Source | 08 |
| Date Received | 2008-09-29 |
| Date of Report | 2008-09-22 |
| Date Mfgr Received | 2008-09-22 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2009-03-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL TROTTER |
| Manufacturer Street | 12919 EARHART AVE |
| Manufacturer City | AUBURN CA 95602 |
| Manufacturer Country | US |
| Manufacturer Postal | 95602 |
| Manufacturer Phone | 5308871008 |
| Single Use | 0 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DICOM BOX (AAM CA) |
| Generic Name | DIGITIZER, IMAGE, RADIOLOGICAL (LMA) |
| Product Code | LMA |
| Date Received | 2008-09-29 |
| Model Number | AAM CA |
| Catalog Number | 100-00638-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAI TECH PRODUCTS, INC. |
| Manufacturer Address | AUBURN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-29 |