MAUDE Adverse Event Report: TELEFLEX MEDICAL CIRCUIT ACCESSORY,HEATED WIRE, INSPIRATO; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 780-20

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review could not be conducted since the lot number was not provided.The product instructions for use (ifu) lbl007014 r00 contains warnings about the care and proper use of product.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of the alleged defect reported it is necessary to evaluate the sample involved on this complaint.No corrective action can be established at this time.A sample is not available for evaluation and it is unknown if the product was used according with the instructions for use.If the device sample becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges "circuit was placed on patient and therapist walked away.They returned to find a hole burnt into the circuit." it was reported there was no injury to the patient.Patient condition reported as "fine".

Manufacturer Narrative

Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the melted portion of the circuit is approximately 34 inches from the column end of the circuit.The melted section of the circuit limb measures approximately 6 inches in length.Within the 6 inch span of heavy melted plastic, 2 severe complete melt through areas exist which display bare heating wire.The heated wire is not gathered or "bunched" anywhere along the length of the circuit limb, and the heated wire is not physically charred (burned).To ensure the correct heated wire was installed into the circuit from the manufacturer, the electrical resistance of the inspiratory limb was measured.The resistance value was found to be within the specified resistance range.The instructions for use (ifu) for this product was reviewed as a part of this complaint investigation.The ifu warns the end user, "when using heated-wire ventilator circuits, be sure that the electrical requirements of the circuit and the heated humidifier are compatible.Incompatibility may result in melting of corrugated tubing or heated-wire element".(con't) other remarks: the ifu also instructs the user, "do not milk or stretch tubing to remove condensation.Wire damage or circuit malfunction may occur".Ifu also states, "do not place tubing directly on patient's skin.", and, "do not cover tubing with sheets, blankets, towels, clothing, or other materials".The reported complaint of a melted circuit was confirmed based upon the sample received.The returned circuit was melted with several sections of exposed heater wire as a result of improper maintenance during use.The defect was discovered during patient use.All circuits are 100% inspected for proper operation and heated wire placement at the time of manufacturing; therefore, it is unlikely that this defect was present at that time.Based upon the damage observed on the returned sample and the information provided, it was determined that operational context caused or contributed to this event.

Event Description

Customer complaint alleges "circuit was placed on patient and therapist walked away.They returned to find a hole burnt into the circuit." it was reported there was no injury to the patient.Patient condition reported as "fine".

• Brand Name: CIRCUIT ACCESSORY,HEATED WIRE, INSPIRATO
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• 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: 6823625
• MDR Text Key: 83895095
• Report Number: 3004365956-2017-00338
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• 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