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

Model Number RT021

Device Problems Crack (1135); Split (2537)

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

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt021 is sold in the usa but has no 510(k) number as it is considered a class i device.We are currently in the process of obtaining further information from the hospital to determine if the complaint rt021 catheter mounts caused or contributed to the reported event.We are also attempting to obtain the subject complaint device for further investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that three rt021 catheter mount tubings have "split".No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt021 is sold in the usa but has no 510(k) number as it is considered a class i device.Method: the rt021 catheter mounts were not returned to fph in (b)(4) for inspection.Our analysis is accordingly based on the previous investigations of similar complaints and our product knowledge.Results / conclusion: we are unable to determine the cause of the reported damage without the complaint devices.All rt021 catheter mounts are pressure tested prior to being released for distribution.Any catheter mount with a split tube would have failed the pressure test.This suggests that the returned catheter mount 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 field representative that three rt021 catheter mount tubings have "split".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: jonathan stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6510575
• MDR Text Key: 73562667
• Report Number: 9611451-2017-00357
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• 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: 2100095405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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