MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-04-01 for CB 500 GX CB 500 G1-15-3-0 manufactured by Imaging Science International, Llc.
[18840088]
Operator received an electrical shock while turning on the machine also complained about machine not working.
Patient Sequence No: 1, Text Type: D, B5
[19117762]
The transformer and circuit breaker were replaced on the unit. The device investigation is ongoing, upon completion, the summary of the evaluation will be submitted as a follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530069-2010-00002 |
| MDR Report Key | 1656101 |
| Report Source | 01,07 |
| Date Received | 2010-04-01 |
| Date of Report | 2010-04-01 |
| Date of Event | 2010-03-15 |
| Date Mfgr Received | 2010-03-16 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2010-09-17 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH LAZARO, SPECIALIST |
| Manufacturer Street | 1910 NORTH PENN ROAD |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2679540365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CB 500 |
| Generic Name | SYSTEM, X-RAY, EXTRAORBITAL |
| Product Code | MUH |
| Date Received | 2010-04-01 |
| Model Number | GX CB 500 |
| Catalog Number | G1-15-3-0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMAGING SCIENCE INTERNATIONAL, LLC |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-01 |