[6620]
On 6/18/93 rptr purchased the device. On 7/28/93 the unit surged while in use with one of rptr's pts. She was very alarmed and reported that her pain had increased for several days following the incident. Following this incident, rptr was assured that the unit was safe to continue to use on rptr's pts by distributor's representative. In july and august of 1993 rptr also had problems with having to turn the machine up to very high levels in order for the pt to feel the appropriate sensation. The device was sent in for repair in late august. The repair ticket states that the low frequency had been customized from 10-100 hz and the high frequency from 95-150 hz. The operators manual states that default settings are 0-10 hz for low frequency and 150 hz for high frequency. The repair ticket states that the unit was recalibrated by the mfr. Rptr experienced no other problems with the unit until 1/7/94. Rptr applied interferential electrical stimulation to a pt's low back using four electrodes. The intensity was set at six. Rptr was using the machine in the manner which she had been instructed to do so by the distributor's representative. As the rptr went to look at the time remaining on the screen it said 2 min 45 sec. At that moment, her pt's back arched off of the table and he screamed with pain. Rptr saw the screen on the unit go from the timer screen to lock onto one of the screens it runs through when it calibrates itself. She immediately turned off the machine and unplugged it from the outlet. The pt was unable to get up from the table for 10-15 minutes. The machine was returned to the mfr but they were unable to reproduce the problem. (*)
Patient Sequence No: 1, Text Type: D, B5