MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-05 for HGM PCC-EDO 2.5W PC-EDO 2.5W NON-SMART OLS01B2B01D manufactured by Hgm, Inc..
[136599]
Equipment had been awaiting installation by hgm, since early september 1999. The co was unable to complete the install, "due to personnel problems". After repeated requests were made a rep was dispatched and he attempted to operate the laser. The unit's circuit breaker tripped and would not reset. When the case was opened, no obvious fault was seen so power was returned and an arc was seen to rise from the power supply, accompanied by a loud pop. A wire was found to have insulation damage due to contact with a metal case. This was repaired, but the system still would not work. The hgm rep said the problem was due to some "leaky" capacitors that "should never have been in the production area, as they were known to be bad... " reporter is still waiting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017495 |
| MDR Report Key | 248885 |
| Date Received | 1999-11-08 |
| Date of Report | 1999-11-03 |
| Date of Event | 1999-10-27 |
| Date Added to Maude | 1999-11-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM PCC-EDO 2.5W |
| Generic Name | LASER |
| Product Code | GFX |
| Date Received | 1999-11-05 |
| Returned To Mfg | 1999-11-03 |
| Model Number | PC-EDO 2.5W NON-SMART |
| Catalog Number | OLS01B2B01D |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 241116 |
| Manufacturer | HGM, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-08 |