Model Number HNICU-37 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An internal complaint ((b)(4)) was received indicating that a neonatal skin temperature sensor (part hnicu-37, lot 52959678) was being used with a warmer when the warmer alarmed.The warmer indicated the neonate's temperature was low when it was in fact normal or high.The warmer was found to be working properly when serviced.The investigation is ongoing.This report will be updated when new or critical information is available.
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Event Description
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A warmer alarmed, notifying the baby's temperature registered as low.However, the temperature was normal or high, and the warmer continued to increase temperature.The warmer was checked by biomed and serviced by ge.It was confirmed the warmer was functioning as it should.
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Manufacturer Narrative
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Root cause: no root cause was identified.Production records were reviewed with no issues found, and the returned samples were functionally tested and found to be within product specification.Corrective action: a corrective action has not been taken due to the root cause determination.An internal complaint ((b)(4)) was received indicating that a neonatal skin temperature sensor (part hnicu-37, lot 52959678) was being used with a warmer when the warmer alarmed.The warmer indicated the neonate's temperature was low when it was in fact normal or high.The warmer was found to be working properly when serviced.Four samples were returned and functionally tested.All results were found to be within specification.No issues were identified.The device history record for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The sub-assembly work orders also were reviewed with no issues found.Product in process was inspected.A total of 80 samples were tested.All results were passing.A corrective and preventive action investigation has been opened to further investigate this issue.This report will be updated at the conclusion of the capa investigation.
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Event Description
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A warmer alarmed, notifying the baby's temperature registered as low.However, the temperature was normal or high, and the warmer continued to increase temperature.The warmer was checked by biomed and serviced by ge.It was confirmed the warmer was functioning as it should.
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Search Alerts/Recalls
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