[19891253]
The hewlett packard fetal heart monitor was used externally to monitor fetal heart rate during labor from 2140 on 4/20/92 to 0210 4/21/92, when infant delivered. The monitor strip revealed no signs of fetal distress and a viable, healthy newborn was anticipated. Spontaneous vaginal delivery of an infant female was complicated by a tight nuchal cord that was cut and clamped prior to the delivery of the shoulder. Apgar's were 2 at one minute, 2 at five minutes and 5 at ten minutes. The baby was resuscitated, transferred to the nursery and continued to improve. Baby was discharged home on 4/25/92 with the following diagnosis: 35 week aga newborn, perinatal depression, possible left-sided grade 1 intraventricularhemorrhage and status post transient tachypnea of the newborn. She received an occupational therapy consult while in the nursery and will be followed by occupational therapy at 2 months of age. Key higby of hewlett packard was notified of the incident. The monitor has been secured for further evaluation on site. 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: 01-feb-92. Service provided by: independent service organization. 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: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5