MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; ELECTRONIC THERMOMETER

Catalog Number 395-90

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the probe is not working when used with the heater.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the probe is not working when used with the heater.

• Brand Name: HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A
• Type of Device: ELECTRONIC THERMOMETER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5126281
• MDR Text Key: 27418930
• Report Number: 3003898360-2015-00720
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1