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 03/07/2017

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 mount caused or contributed to the reported event.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 the rt021 catheter mount tubings have "split".This was found before patient use.

Manufacturer Narrative

The rt021 is sold in the usa but has no 510(k) number as it is considered a class i device.Method: six complaint rt021 catheter mounts (two units in unsealed bags and four units in sealed bags) and additional (b)(4) catheter mounts in sealed bags were returned to fisher & paykel healthcare in (b)(4) for investigation, and were visually inspected.In addition, two of the returned complaint units (in sealed bags) were leak tested.Results: visual inspection revealed that the tubing cuff of the returned complaint catheter mounts had split at the connector end.Leak test of the two returned complaint units (in sealed bags) revealed that these units were out of specification.No fault was found with the returned sealed (b)(4) catheter mounts.Conclusion: we are unable to determine the cause of the damage observed on the returned rt021 catheter mounts.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 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 field representative that the rt021 catheter mount tubings have "split".This was found before patient use.

• 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: 6470905
• MDR Text Key: 72428764
• Report Number: 9611451-2017-00309
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• 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: 2100095405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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