MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number 900PT290E

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We are in the process to determine if fph's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the mr290v vented autofeed humidification chamber leaked water from the base.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Correction: when the mr290 humidification chamber was returned to fph (b)(6) it was found to be a 900pt290e humidification chamber.Mr290 and 900pt290e humidification chambers are the same, but have different model names.Method: the complaint 900pt290e humidification chamber was returned to fph in new zealand for evaluation.The complaint device was visually inspected and performance tested.Results: visual inspection revealed that the chamber was not damaged.The performance test showed that the chamber did not leak.Conclusion: no fault was found with the returned chamber.We are unable to determine what may have caused the problem reported by the customer.Every 900pt290e chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails either of these tests is rejected.The returned chamber would have met the required specification at the time of production.

Event Description

A hospital in the (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the mr290v vented autofeed humidification chamber leaked water from the base.No patient consequence was reported.

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• 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 drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6662672
• MDR Text Key: 78483166
• Report Number: 9611451-2017-00585
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT290E
• Device Catalogue Number: 900PT290E
• Device Lot Number: 1610311851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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