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

Model Number 900PT290E

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint 900pt290e autofeed chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the 900pt290e autofeed chamber had water filling above the maximum fill line.Conclusion: without the complaint device, we are unable to determine what has caused the reported event.Every 900pt290e 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.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject chamber would have met the required specification at the time of production.Our user instructions that accompany the 900pt290e autofeed chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "appropriate patient monitoring must be used at all times".

Event Description

A distributor in myanmar reported that a 900pt290e autofeed chamber had water filling above the maximum fill line.There was no reported patient consequence.

• Brand Name: 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: 11368600
• MDR Text Key: 233249032
• Report Number: 9611451-2021-00203
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900PT290E
• Device Catalogue Number: 900PT290E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• 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