MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM III+ HEATER,21 VOLT; RESPIRATORY GAS HUMIDIFIER

Catalog Number 380-88R

Device Problem Overheating of Device (1437)

Patient Problems Superficial (First Degree) Burn (2685); No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2008

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Inspection and testing of the unit following its return to teleflex revealed no functional issues that could have caused or contributed to the alleged overheating.The unit was refurbished and returned to service at another hospital, where it was used without incident.The complaint of overheating cannot be confirmed.

Event Description

The customer alleges that a patient (neonate) received first-degree burns while undergoing treatment.There is no report of a treating physician to indicate that medical intervention was required, nor as to the condition of the patient.

• Brand Name: HUDSON CONCHATHERM III+ HEATER,21 VOLT
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5761428
• MDR Text Key: 48527329
• Report Number: 3003898360-2016-00696
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 380-88R
• Device Lot Number: 11276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2009
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other