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

Model Number MR290V

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that a baxter water bag burst while the rt324 infant breathing circuit was in use with a fabien ventilator.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint mr290 autofeed humidification chamber was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Therefore, our investigation is based on the information provided by the hospital and our knowledge of the product.The hospital reported that the baxter water bag used with the rt324 breathing circuit and mr290 chamber burst when connected to the circuit.Without the return of the complaint devices we are unable to determine what may have caused the problem experienced by the customer.The user instructions which accompany the mr290 chamber state the following: - "set appropriate ventilator alarms." - "maximum operating pressure: 8kpa.".

• Brand Name: VENTED AUTOFEED CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 4570969
• MDR Text Key: 5552882
• Report Number: 9611451-2015-00123
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: BAXTER WATER BAG; FISHER & PAYKEL HEALTHCARE RT324 BREATHING CIRCUIT; FABIEN VENTILATOR