[18599848]
Picker intl, inc. 595 miner rd, highland heights, oh 44143. Picker intl inc hs been rquested to provide info concerning an incident involving a radiation therapy unit. 1. The model number is 558. 2. The serial number is 611, 3. The unit is over forty years old. The reported failure of the cable and resistor can be attributed to age and use. 4. No testing of the device was performed. No failure analysis was performed beyond determining that the failure of the cable and resistor can be attributed to age. 5. The rptr, a medical physicist from the reporting facility, stated that the unit was operating at half the specified voltage. He did not indicate if the current meters indicated lower than normal current or if one of the current meters indicated an abnormal reading. Picker did not repair this unit. 6. No evaluation was made to determine if the event was attibutable to the device. 7. There is no statement in the labeling concerning this event. There are no other incidents reported in the last twenty years concerning this event. In a forty year old device, some failures will occur due to age. 8. No remedial action is planned because this is the only reported case in twenty years. 9. There is no current labeling for the device as this device has not been sold for twenty-five years. Attached is a copy of the latest manual and literature.
Patient Sequence No: 1, Text Type: D, B5