Model Number 989803137631 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)
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Patient Problem
No Code Available (3191)
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Event Date 03/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted once the investigation is complete.The patients were twins (mfr report# 1218950-2016-02176 addresses patient 1 and mfr report# 1218950-2016-02177 addresses patient 2).
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Event Description
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It was reported that the fetal monitor provided inaccurate fetal heart rate measurement data.It was reported that the patient required emergent care (intubation and incubation).
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Manufacturer Narrative
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There was no material returned for evaluation.According to the hospital risk manager, the product was discarded before risk management was made aware of the incident.When asked if it was being considered that the patient issues were the direct result of the delay in acquiring ecg signals / monitoring of the infants, the hospital risk manager reported that the troubleshooting time delayed monitoring of the patient, but that the delay in monitoring was not determined to be the result of a philips product failure.The product involved in the incident was discarded by the customer.There is no indication that the product malfunctioned.The hospital risk manager indicates that a philips representative visited their facility and provided a review/training of the use of the fetal spiral electrodes with 71 hospital staff members and that there have been no further issues/incidents since this incident.
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Event Description
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The customer indicated that they were unable to acquire fetal heart rate via the (b)(4) fetal spiral electrodes (fse) due to difficulty in deploying the fses.The customer indicated that the infant had apgar scores of 1,3,4.It was reported that the infant required emergent care (resuscitation, intubation, body cooling for 3 days with morphine drip for comfort).The patient was reportedly discharged before 10 days of life with ¿good outcome¿.It was reported that ongoing outpatient follow-up is being performed to assess for developmental issues.
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Search Alerts/Recalls
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