MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD CATHETER MOUNT; BZO

Model Number RT021

Device Problems Device Issue (2379); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt021 catheter mount is sold in the usa but has no 510(k) number as it is considered a class i device.Method: only two complaint rt021 catheter mounts were returned to fph in (b)(4) for investigation, where they were visually inspected.Results: visual inspection of both devices revealed that the tubing at the swivel end had split.Conclusion: we were unable to determine the cause of the damaged observed on the returned rt021 catheter mounts.All rt021 catheter mounts are pressure tested prior to release for distribution.Any catheter mount with a split tube would have failed the pressure test and be rejected from the production line.This suggests that the returned catheter mounts were damaged after they were released for distribution.Our user instructions that accompany the rt021 catheter mount state the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the connectors of three rt021 catheter mounts had cracked during patient use.No patient consequence was reported.

• Brand Name: CATHETER MOUNT
• Type of Device: BZO
• 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 dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6386349
• MDR Text Key: 69329448
• Report Number: 9611451-2017-00160
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT021
• Device Catalogue Number: RT021
• Device Lot Number: 2100074251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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