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

Model Number MR290V

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 vented autofeed humidification chamber is expected, but has not yet been returned to fisher & paykel healthcare in (b)(4).We will send a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6), reported via a fisher & paykel healthcare representative, that holes were found in the aluminium base of the mr290 vented autofeed humidification chamber.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr290 vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Further information was requested from the hospital, however no further information was provided.A photograph of the complaint device was provided by the hospital.Our investigation is thus based on the photograph provided by the hospital, previous similar incidents and our knowledge of the product.Results: visual inspection of the photographs provided showed two holes in the base of the complaint m290 chamber.The edges of the holes appeared to be rough and the chamber base was found to be corroded around the holes.Conclusion: without the return of the complaint device, we are unable to determine what may have caused the reported failure.However, it is known that the use of nebulizing drugs or the use of a liquid other than sterile water may lead to degradation of the mr290 chamber.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 chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v humidification chambers state the following: "use usp sterile water for inhalation or equivalent." "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "set appropriate ventilator alarms.".

Event Description

A distributor in mexico reported via a fisher & paykel healthcare representative that holes were found in the aluminium base of the mr290 vented autofeed humidification chamber.No patient consequence was reported.

• 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
• MDR Report Key: 7875646
• MDR Text Key: 120255014
• Report Number: 9611451-2018-00784
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P RT202 ADULT DUAL-HEATED BREATHING CIRCUIT