MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM III HEATHER; HEATED HUMIDIFIER

Catalog Number 380-80R

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); Vitrectomy (2643)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The customer alleges that the heater will not heat during pre-testing.No patient injury reported.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed sine the device sample is not available to perform a proper device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend of similar complaints.

• Brand Name: HUDSON CONCHATHERM III HEATHER
• Type of Device: HEATED HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4736408
• MDR Text Key: 20119025
• Report Number: 3003898360-2015-00294
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 380-80R
• Device Lot Number: REFURB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1