MAUDE Adverse Event Report: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT; BTT

Model Number 900MR810

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint 900mr810 adult heated wall reusable breathing circuit is currently en route to fisher & paykel healthcare (f&p) in (b)(4) for evaluation to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported that a 900mr810 adult heated wall reusable breathing circuit was damaged and caused an air leak and the ventilator to alarm.There was no patient consequences.

Manufacturer Narrative

(b)(4).Method a complaint 900mr810 adult heated wall reusable breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation and visually inspected.Result: visual inspection revealed that the tube of 900mr810 breathing circuit was damaged.Conclusion: we are unable to determine what caused the damage of the breathing circuit.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The complaint device would have met the specification at the time of production.Our user instructions that accompany the 900mr810 adult heated wall reusable breathing circuit state the following: "inspect circuit before re-use, do not use if the circuit shows signs of deterioration, such as: cracks, tears, or damage." "perform a pressure and leak test on the breathing system, and check for occlusions, before connecting to a patient." "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".

Event Description

A healthcare facility in canada reported that a 900mr810 adult heated wall reusable breathing circuit was damaged and caused an air leak and the ventilator to alarm.There was no patient consequences.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Type of Device: BTT
• MDR Report Key: 9541205
• MDR Text Key: 181958954
• Report Number: 9611451-2020-00005
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2020
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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