MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR TUBING KIT; BTT

Model Number RT330

Device Problem Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt330 circuit was received at fisher & paykel healthcare (b)(4) for evaluation.The inspiratory limb was visually inspected and the resistance of the heater wire was checked with a calibrated multimeter.Results: visual inspection confirmed that there was condensation in the inspiratory limb, as is expected from a circuit used with a humidification system.The resistance test showed that the inspiratory heater wire was within specification.Conclusion: it is likely that the condensation entered the patient's air path as a result of the movement of the patient from bed to his parent.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.The user instructions that accompany the rt330 include the following statements: attention: - patient monitoring is recommended.Warning: - when mounting a humidifier adjacent to a patient ensure that the humidifier is always positioned lower than the patient.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (fph) field representative that "a lot of condensation" was observed in the inspiratory limb of an rt330 infant breathing circuit during use.The patient was being treated with the rt330 and an opt314 infant nasal cannula.When the patient was being transferred from bed to parent, some condensation passed into the patient's nose and was swallowed by the patient.There was no further patient consequence.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr.; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7057356
• MDR Text Key: 93476462
• Report Number: 9611451-2017-01094
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/23/2017
• 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