MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-22 for TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE manufactured by Cardiogenesis Corporation.
[5199269]
During a preventative maintenance on tmr laser ((b)(4)),the laser would shut down if the key was flexed in the key switch. The laser system is 15 years old and it is not unusual for the switch to wear in this manner. The key switch was replaced and the issue was resolved. The complainant stated that she had not had any incident of system shut down.
Patient Sequence No: 1, Text Type: D, B5
[12674359]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[34411621]
Cryolife was informed that during a preventative maintenance (pm) on transmyocardial revascularization (tmr) laser (s#(b)(4)), the laser would shut down if the key was flexed in the key switch. The laser system is 15 years old and it is not unusual for the switch to wear in this manner. The key switch was replaced and the issue was resolved. There was no user complaint of this happening and specialty team manager for cardiac surgery, (b)(6) stated that she had not had any incident of system shut down. A report was issued stating that there is not a service contract with the account and therefore no previous service records exist on file for the laser. Cryolife issued a no charge purchase order (po) for a one time preventative maintenance on the unit as the hospital had requested the system be checked out since it had not been done in some time. The event could be duplicated by manipulating the key in the key switch, which would cause system to cycle off. There was no further inspection of the key switch and diagnostics after replacing the faulty key switch. Worn key switch was replaced with a new key switch (sp2276) during the scheduled routine preventative maintenance cycle. There was no evidence to suggest that an error or deficiency occurred at cryolife. All steps of the quality assurance verification were completed, including a startup of the console via the key switch, as well as the final test laser power output with all results being within specification ranges. There were no problems requiring corrective action documented on the final product corrective action list portion of the final test/quality assurance procedure. There were no additional non-conformances or reworks included in the manufacturing and final inspection records.
Patient Sequence No: 1, Text Type: N, H10
[34411622]
During a preventative maintenance on tmr laser (s#(b)(4)),the laser would shut down if the key was flexed in the key switch. The laser system is 15 years old and it is not unusual for the switch to wear in this manner. The key switch was replaced and the issue was resolved. The complainant stated that she had not had any incident of system shut down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950727-2014-00026 |
| MDR Report Key | 4352803 |
| Report Source | 07 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2014-12-09 |
| Date Added to Maude | 2015-01-08 |
| 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 |
| 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 | CARDIOGENESIS CORPORATION |
| 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 | TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Generic Name | TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE |
| Product Code | MNO |
| Date Received | 2014-12-22 |
| Operator | SERVICE PERSONNEL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOGENESIS CORPORATION |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-22 |