Device evaluation of monitor sn (b)(4) has been completed. the reported problem (does not recognize therapy electrode connection) has been confirmed. upon investigation the monitor displayed a service code 204 (belt/monitor unusable) and was unable to recognize a therapy electrode connection intermittently. the cause for the failure was isolated to a defective u612 inverting charge pump on the computer/analog pca.The root cause for the defective u612 component could not be positively identified. root cause investigation of similar failures has determined that damage to the electrode belt cables can cause damage to the u612 inverting charge pump.No adverse event resulted from the damaged monitor.
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