MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-01-14 for APX 525 X-RAY GENERATOR 110-0128G2 APX525 manufactured by Del Medical Inc..
[17469561]
The event happened to a service engineer not a patient. With the x-ray generator turned off, the service engineer was removing debris from a blown inverter fuse and received an electrical shock as he made contact with the dc rail with his hand. The reflex from the shock caused his hand to pull back and make contact with a sharp object within the generator housing cutting his hand. He went to the hospital, was treated for the cut on his hand and released the same day.
Patient Sequence No: 1, Text Type: D, B5
[17596471]
The service engineer was in the process of replacing some old printed circuit boards when a fuse blew. He failed to fully discharge the capacitors before working on internal circuitry as explained in the manual and the resulting shock caused the reported injury. This injury was not a result of a device malfunction but a failure of the service engineer to observe proper electrical safety techniques and warnings. Conclusion: service error caused the event. In our review of this event there was some uncertainty as to whether the reported injury fit the fda definition of serious injury. We take all injuries seriously and felt it was better to report this event than not.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418964-2011-00001 |
| MDR Report Key | 1966528 |
| Report Source | 00 |
| Date Received | 2011-01-14 |
| Date of Report | 2011-01-10 |
| Date of Event | 2011-01-10 |
| Date Mfgr Received | 2011-01-10 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2012-05-08 |
| 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 | WILLIAM KOSTECKI |
| Manufacturer Street | 50 GARY AVE., STE. B |
| Manufacturer City | ROSELLE IL 601725 |
| Manufacturer Country | US |
| Manufacturer Postal | 601725 |
| Manufacturer Phone | 8472887022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APX 525 X-RAY GENERATOR |
| Product Code | IZO |
| Date Received | 2011-01-14 |
| Model Number | 110-0128G2 |
| Catalog Number | APX525 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEL MEDICAL INC. |
| Manufacturer Address | ROSELLE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-14 |