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

Model Number MR290HFV

Device Problems Crack (1135); Fluid/Blood Leak (1250); Moisture Damage (1405); Material Separation (1562)

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

Event Date 08/12/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that during cpap treatment on a baby an mr290hfv humidification chamber cracked and the water ran out as the chamber dome became separated from the chamber base.They reported that this happened with two chambers.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint mr290hfv chambers have not been received at fisher & paykel healthcare for evaluation.Without the devices we are unable to determine what may have caused the issue as reported by the customer.However it is known that some cpap ventilators are capable of producing pressures in excess of 80cmh2o.The integrity of the chamber can be affected when pressures exceed 80cmh2o.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.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 chambers would have met the required specification at the time of production.Our user instructions that accompany the mr290hfv state the following: - use of the mr290 above the maximum operating pressure [8kpa (~80cmh2o)] may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.

• Brand Name: HIGH FREQUENCY 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4083818
• MDR Text Key: 17160548
• Report Number: 9611451-2014-00762
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290HFV
• Device Catalogue Number: MR290HFV
• Device Lot Number: 140521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• 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 RT324 INFANT BREATHING CIRCUIT