MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; RESPIRATORY GAS HUMIDIFIER

Catalog Number 880-15KIT

Device Problems Air Leak (1008); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2016

Event Type  malfunction  

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.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the device sample involved in this complaint.However as an additional test, samples of current production p/n 880-15kit were reviewed and inspected functionally observing for any issue that could be related with the customer complaint and no issues were found.If device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that there was some air from area of the circuit that looked like there had been some minor melting.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the circuit had a 3/8 inch melt that runs parallel with the rib.No other issues were observed.There are no visual signs of the circuit being "milked".There were no signs of the heater wire being "gathered" or "bunched" , which might cause a hot spot.The melted portion of the rib only measures approximately 3/8 inch which is not indicative of a bed linen burn.The electrical resistance of the heated wires was measured and found to be well within specified limits.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be determined.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that there was some air from area of the circuit that looked like there had been some minor melting.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5708751
• MDR Text Key: 46882456
• Report Number: 3004365956-2016-00236
• 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: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 880-15KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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