Model Number 989803137631 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
|
Patient Problem
Foreign Body In Patient (2687)
|
Event Type
Injury
|
Manufacturer Narrative
|
Unable to confirm serial number.A follow-up report will be submitted upon completion of the investigation.Additional information has been requested as philips is still in the process of assessing the incident.
|
|
Event Description
|
The customer reported the tip of 989803137631 fetal spiral eletrode broke and remained in the baby's scalp.The tip was discovered by a relative of the baby several hours after birth.It is not known if emergent care was needed.
|
|
Manufacturer Narrative
|
No material was returned for evaluation.The electrode is to be inspected after it has been disengaged for completeness.There is no indication of an increasing or systemic trend; therefore no additional action was deemed warranted.We are considering this complaint to be a product malfunction.It appears that the instructions for use were not followed.It is not known if training was provided to the customer.There has been no response for additional information.
|
|
Search Alerts/Recalls
|