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

Model Number RT330

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt330 was not returned to fisher & paykel healthcare for evaluation.The probe-probe port connection is a taper fit and when firmly placed in the probe ports the probes form a tight seal and require twisting and pulling to be removed.Without a complaint device to evaluate we cannot determine if there was any defect with the subject circuit.It is most likely that either the probe was not properly inserted and came loose or that it was accidentally pulled out of the probe port.The user instructions that accompany the rt330 show in pictorial format how to insert the probes into the inspiratory limb probe ports.They also include the following statements: check all connections, caps and/or plugs are tight.Patient monitoring is recommended.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the temperature probe fell off from the chamber end of the rt330 infant optiflow circuit and an air leaked from the port during use.The patient's oxygen level dropped but returned to normal level when the probe was replugged.No further patient consequence was reported.

• 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 8871947
• MDR Text Key: 175282837
• Report Number: 9611451-2019-00771
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/09/2019

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
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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