[19252]
Patient monitored uterine activity on 9/25/94 at 1555. Device would not transmit data over the phone lines despite repeated trouble shooting attempts, monitor was replaced with another monitor on 9/25/94. Patient monitored uterine activity using new device and data would not transmit over the phone lines despite repeated trouble shooting attempts, patient was not symptomatic for preterm labor at this time. At 2009 on 9/25/94, patient was instructed to call clinic with any s/s of preterm labor or if she felt any uterine contractions. This clinic was planning to call the patient's insurance company in the morning to discuss using a different type of monitor since there was transmission problems with the monitor and the patient's phone. On 9/26/94 at 0343, the patient's husband called stating that his wife was contracting. Appropriate clinical actions were taken. At 0424, patient's husband called again stating his wife had 2 hard contractions. There was no uterine activity data available since the 2 monitors wound not transmit. Subsequently, the patient went to the hospital at 0500, had cervical dilation to 3-4cms, and was stablized on iv mag sulfate. Patient was 28 + 1 weeks gestation at the time of the incident. Patient was also on the sp infusion pump for terbutaline therapy. No malfunction or user error occured with this device. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5