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

Model Number MR290V

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 humidification chamber is en route to fisher & paykel healthcare in (b)(6) for further investigation.We will provide a follow-up report once we have completed our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare representative that the mr290 humidification chamber was coming apart when using for cpap therapy.There was no reported patient consequence.

Event Description

A healthcare facility in denmark reported via a fisher & paykel healthcare representative that the mr290 humidification chamber was coming apart while being used for cpap therapy.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).We received two mr290 chambers for investigation: the complaint chamber plus an unused, sealed chamber.Lot number manufacture date 120606 6 june 2012.140408 8 april 2014.Method: the mr290 chambers were visually inspected.Result: visual inspection revealed no damage to the two returned chambers.Conclusion: we were unable to determine what caused the problem reported by the customer as no fault was found with the returned complaint chamber.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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.The user instructions that accompany the mr290v chamber state the following: - maximum operating pressure: 8 kpa - 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.- do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.

• 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
• MDR Report Key: 7489568
• MDR Text Key: 107725152
• Report Number: 9611451-2018-00363
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2018
• 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: 140408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER; FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER; FISHER & PAYKEL HEALTHCARE RT224 BREATHING CIRCUIT; FISHER & PAYKEL HEALTHCARE RT224 BREATHING CIRCUIT