MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD END EXPIRATORY FILTER; CAH

Model Number RT020

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of retrieving further information.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an rt020 end expiratory filter became blocked after approximately 4-6h of use on a patient.As a result, they were not able to obtain inspiratory tidal volume (vti) from the ventilator.After changing the filter the issue was resolved.There was no medical intervention required.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).The rt020 end expiratory filter is a single use product designed as bacterial/viral filter to prevent contamination of the ventilator by microorganisms present in the ventilatory gases of patients undergoing treatment.Method: the complaint rt020 filter was received at the fisher & paykel healthcare regional office in uk for evaluation.Our assessment is based on the physical inspection of the device, information provided by the customer and our knowledge of the product.Results: the customer reported that the filter was found to be "soaking wet" at the time of the incident.Visual assessment of the device at our f&p the regional office in uk showed that the outer insulation case of the rt020 end expiratory filter was missing.Conclusion: we are unable to conclusively determine the root cause of the event.However it is known that the use of the filter without the insulation case could lead to an increase in condensation inside the filter.Rt020 end expiratory filters are visually inspected and pressure tested for leaks before leaving the production line, and those that fail are rejected.The subject rt020 filter would have met the required specifications at the time of production.This suggests that the insulation case was removed after the product was released for distribution.Our user instructions which accompany the rt020 filter state: - change every 24 hours or sooner if noticeable deterioration occurs, following standard hospital procedure.Our user instructions which accompany the rt380 evaqua2 breathing circuit state: - check breathing circuits for condensation every 6 hours and drain if required.

Event Description

A hospital in dublin reported via a fisher & paykel healthcare (f&p) field representative that an rt020 end expiratory filter became blocked after approximately 4-6h of use on a patient.As a result, they were not able to obtain inspiratory tidal volume (vti) from the ventilator.The filter was immediately replaced, and the issue was resolved.There was no medical intervention required.There was no patient consequence.

• Brand Name: END EXPIRATORY FILTER
• Type of Device: CAH
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8360713
• MDR Text Key: 137842717
• Report Number: 9611451-2019-00133
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K050927
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT020
• Device Catalogue Number: RT020
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P RT380 ADULT BREATHING CIRCUIT; F&P RT380 ADULT BREATHING CIRCUIT; MAQUET SERVO-U VENTILATOR; MAQUET SERVO-U VENTILATOR