MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-04-13 for SOLARGEN 2100S CONSOLE LSR-SG2100S manufactured by Cryolife, Inc..
[5643258]
According to the report, the field service engineer "arrived at the site to perform normal semi-annual maintenance. After system evaluation, i determined that the laser head efficiency was extremely low. Attempted to increase by alignment and calibration but was unsuccessful. Replaced laser rod, cleaned cavity and reinstalled. Complete system alignment and calibration performed. System operating to factory specification on departure. No complaint was lodged nor alluded to by hospital personnel. "
Patient Sequence No: 1, Text Type: D, B5
[13132582]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[39041863]
According to the report, the field service engineer "arrived at the site to perform normal semi-annual maintenance. After system evaluation, i determined that the laser head efficiency was extremely low. Attempted to increase by alignment and calibration but was unsuccessful. Replaced laser rod, cleaned cavity and reinstalled. Complete system alignment and calibration performed. System operating to factory specification on departure. No complaint was lodged nor alluded to by hospital personnel. " a review of manufacturing records for solargen laser console veg01 was performed. According to the device history record (dhr) for solargen console veg01, all manufacturing procedures and final testing performed at (b)(4) are documented as being completed and verified by (b)(4) quality control department prior to its release. The system is documented as being able to proceed through the start-up sequence successfully and efficiency testing and calibration was completed. All test results recorded from the calibration tests are within specification showing the laser console was functioning properly. A review was performed of the available information. A review of the service records for the console indicated that the laser rod had not been replaced in the past. The account has an active service agreement for the console with cryolife that started on (b)(6) 2013. The flash lamp and hr optic were replaced on 06/24/2013 to increase the efficiency of the optical laser assembly. During the preventive maintenance on 03/18/2015, the console was noted to have 19 lamp hours of use and 98,926 lamp pulses. The maximum voltage of 1450v was exceeded during calibration and the laser rod was replaced. The next preventive maintenance is due on 09/17/2015. A root cause could not be determined for this complaint. Console veg01 is documented as passing all quality testing and inspections prior to its release from (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39041864]
According to the report, the field service engineer "arrived at the site to perform normal semi-annual maintenance. After system evaluation, i determined that the laser head efficiency was extremely low. Attempted to increase by alignment and calibration but was unsuccessful. Replaced laser rod, cleaned cavity and reinstalled. Complete system alignment and calibration performed. System operating to factory specification on departure. No complaint was lodged nor alluded to by hospital personnel. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2015-00040 |
| MDR Report Key | 4686047 |
| Report Source | 07 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-18 |
| Date Added to Maude | 2015-05-13 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLARGEN 2100S CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2015-04-13 |
| Model Number | LSR-SG2100S |
| Operator | SERVICE PERSONNEL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-13 |