MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 395-90

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

Customer complaint alleges "probe stopped working during patient use but did not hurt the patient.Probe was changed out with new probe.".

Event Description

Customer complaint alleges "probe stopped working during patient use but did not hurt the patient.Probe was changed out with new probe.".

Manufacturer Narrative

(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.

• Brand Name: HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7730991
• MDR Text Key: 115362258
• Report Number: 3003898360-2018-00589
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K063758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 395-90
• Device Lot Number: SN:617080262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1