MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-08-14 for MEDLITE C6 659-0002 manufactured by Hoya Conbio.
[516186]
Our service technician was working on a medlite c6 laser at the office. The laser was reporting error 22, which is "no end of charge" which means the hv capacitor is not getting fully charged and the flashlamp was not flashing. He evaluated the system and found the simmer supply was working, the lamp was simmering, but the lamps were not flashing. He decided the hv power supply should be replaced. He reports that he turned the system off, unplugged the system and layed down on the floor to remove the power supply. He disconnected the hv cable from the supply that goes to the hv capacitor, the ac input cable to the supply and the last thing he remembered was removing the control cable to the supply and then he received the shock. The office staff heard a loud bang from the room, found him bleeding from the ears, nose and mouth, and they called the building manager who tried to resuscitate hm. The emergency response team resuscitated him and took him to the hospital for treatment.
Patient Sequence No: 1, Text Type: D, B5
[7832351]
They submitted a report on the site evaluation of the system and interviews with the office personnel and with service technician. The high voltage power supply, scr board and the charge capacitor were returned from the system for further evaluation: the scr board is intact, the high voltage discharge relay and discharge resistors are intact and the resistance that was connected to the charge capacitor to discharge the capacitor measured 33 kilo ohms. This is consistent with the design which has 3,100 kilo ohm resistors in parallel. The high voltage power supply was opened and we found that the bridge rectifier on the input ac was burned and all diodes were shorted, which would not allow the power supply to develop a high voltage output. This is consistent with report which indicated that when they turned on the system, it reported an error 22 and there was no voltage developed on the charge capacitor. In the report, service technician indicated when the system would not flash and was reporting an error 22, he also noticed a burning smell. This is consistent with the burned input bridge rectifier in the power supply. The capacitor was received in good condition. There is some evidence that the threads on one of the posts were damaged, not cross threaded, but the post had some rough spots on the threads. This is consistent with the observation in the report that the nut on the wire going from the charge cap to the scr board was slightly loose. This is the path to rapidly discharge the capacitor. Note the attached spread sheet on discharge times for the primary discharge path and the backup discharge path. It was observed that you could move the wire on the post, that it was not tight, but it also was not sloppy loose. The diameter of the ring lug on the wire that goes on that post is very close to the diameter of the post so there is little chance that the loose wire could have been really disabled from discharging the capacitor. The backup discharge resistor on the capacitor measures 2. 2 megaohms which is consistent with the design. None of the evidence identifies defective components, parts, or design that would cause the accident to happen. The only explanation that is possible is the power supply was able to deposit a charge on the capacitor as it was failing. In addition, the loose nut on the capacitor broke the connection to the fast discharge resistors on the scr board; as a consequence, the back up bleed resistor was discharging the partially charged capacitor when service technician contacted a high voltage point when he was removing the low voltage cables from the pwoer supply. The only conclusion is if he had discharged the high voltage capacitor as he had been recently instructed to do, this accident would not have happened even if one of the system safety discharge circuits was inoperative. Because of the serious nature of the incident, they have taken additional preventative action steps to impress upon the service personnel the importance of following a specific safety regimen when working in and around high voltage. The service bulletin will be incorporated into the service manual, in addition to being sent to the service personnel. Preventative action: a service bulletin has been generated, see attached bulletin 47, which has been emailed to all the service engineers and distributors world wide. This bulletin specifically addresses the safety precautions that must be observed when working in and around high voltage components. It also states the minimum wait time that should be observed before attempting to discharge the high voltage capacitor to allow the back up bleed resistor to discharge the capacitor to minimize the risk if the capacitor is not fully discharged. This service bulletin will be sent via ups with a return receipt tracking requested to verify that all personnel and distributors have received the information. The manufacturing and engineering personnel will be trained in these safety procedures as well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2918486-2006-00001 |
| MDR Report Key | 751983 |
| Report Source | 06 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-08-02 |
| Date of Event | 2006-07-07 |
| Date Mfgr Received | 2006-07-07 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-08-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM GREEN |
| Manufacturer Street | 47733 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104454528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLITE C6 |
| Generic Name | LASER, ND: YAG |
| Product Code | LXS |
| Date Received | 2006-08-14 |
| Model Number | MEDLITE C6 |
| Catalog Number | 659-0002 |
| Lot Number | 2/2005 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 739773 |
| Manufacturer | HOYA CONBIO |
| Manufacturer Address | * FREMONT CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2006-08-14 |