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

Model Number MR290V

Device Problem Air Leak (1008)

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

Event Date 10/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint mr290v vented autofeed humidification chambers caused or contributed to the reported event.

Event Description

A healthcare facility in (b)(4) reported via an fisher & paykel healthcare field representative that two mr290v humidification chambers were found leaking from the base.No patient consequence was reported.

Manufacturer Narrative

(b)(4) the complaint mr290v humidification chambers were not returned to fisher & paykel healthcare in (b)(4) for evaluation, as the customer discarded the complaint chambers.The customer was contacted and two photographs of the complaint chambers and additional information about the reported event could be received.Our investigation is therefore based on the information provided by the customer, a visual inspection of the received photographs and our knowledge of the product.Results: the customer had informed us that the chamber was used for four days respectively before it was leaking.The other chamber was leaking earlier.Visual inspection of the received two photographs revealed no damage to the complaint chambers.Conclusion: without the return of the complaint devices we are unable to determine what may have caused the problem reported by the customer.If the complaint devices were returned it would have been visually inspected and pressure tested for leak.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber including a check for cracks in the chamber dome.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.It was reported that both chambers were in use and that one chamber was in use for four days; this suggests that the problem occurred after the product was released for distribution.The user instructions that accompany the mr290v vented autofeed humification chamber state the following: - use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure.- set appropriate ventilator alarm.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Device was discarded.

Event Description

A healthcare facility in (b)(6) reported via an fisher & paykel healthcare field representative that two mr290v humidification chambers were found leaking 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: raymond yan ; 173 technology dr., suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6078077
• MDR Text Key: 59124260
• Report Number: 9611451-2016-00738
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K934140
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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