TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; HUMIDIFIER, RESPIRATORY GAS, (
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Catalog Number 395-90 |
Device Problem
No Device Output (1435)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for evaluation at the time of this report.Thirty-two devices were taken from the current production p/n 395-90 conchatherm neptune, dual thermistor, ad lot # 73g1800037, and visually inspected.No issues were found that could lead to this complaint.A device history record investigation did not show issues related to complaint.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated with the evaluation results.
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Event Description
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Customer complaint alleges "probe stopped working during patient use but did not hurt the patient.Probe was changed out with new probe.".
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Event Description
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Customer complaint alleges "probe stopped working during patient use but did not hurt the patient.Probe was changed out with new probe.".
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Manufacturer Narrative
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(b)(4).One (1) 395-90 conchatherm neptune, dual thermistor, ad was received for investigation.Upon receipt a visual inspection was performed to determine if the sample displayed any signs of abuse/misuse/damage.At visual inspection it was confirmed that the wire from the short leg of the temperature probe sensor had been pulled out of the heater connector.The complaint has been confirmed as a result of the physical damaged recorded.However, the root cause of "user error - unintentional-cannot determine" was assigned because it is unknown how the wire was detached.No further action required.
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