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

Model Number MR290V

Device Problem Moisture Damage (1405)

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

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare field representative that an mr290v vented autofeed humidification chamber flooded and water went up the rt202 breathing circuit towards the patient.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 autofeed humidification chamber was returned to fisher & paykel healthcare in (b)(4) for evaluation.The chamber was connected to a water bag and tested for performance.Results: no fault was found in relation to the mr290 chamber.During testing water was fed into the chamber and it stopped filling 5mm below the maximum fill line.The float was operating correctly and the chamber performed within specification.A dent was found in the base of the chamber.Conclusion: the water level inside the chamber should not exceed the maximum fill line.We were unable to replicate the reported incident and are therefore unable to determine the cause of the reported event.All mr290 chambers have float function and valve testing performed twice during production.A failure of any test would result in rejection of the chamber before distribution.The user instructions that accompany the mr290 state the following: -"set appropriate ventilator alarms." -"perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

• Brand Name: VENTED AUTOFEED 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3831691
• MDR Text Key: 4396865
• Report Number: 9611451-2014-00438
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 131013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE RT202 BREATHING CIRCUIT