MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT; BTT

Model Number 900MR782

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

A distributor in germany reported via a fisher and paykel healthcare (f&p) field representative, that a 900mr782 reusable neonatal single heated breathing circuit was found damaged.There was no patient involvement.

Manufacturer Narrative

(b)(4).The 900mr782 reusable neonatal single heated breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k913368.We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4) the 900mr782 reusable neonatal single heated breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k913368.Method: the complaint 900mr782 reusable neonatal single heated breathing circuit was not returned to fisher & paykel healthcare (f&p) in new zealand.Our investigation is therefore based on the information and videograph provided by the customer, and our knowledge of the product.Results: visual inspection of the videograph provided by the customer revealed that the reusable neonatal was observed stretched at cuff end.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.However, the tube was most likely to have been stretched.All 900mr782 reusable neonatal single heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the 900mr782 reusable neonatal single heated breathing circuit show in pictorial format the correct set-up of the circuit and also states the following: - "visually inspect products before each use on the patient.Discard if faulty or if there is any sign of deterioration such as cracks, tears or damaged insulation.These may cause gas leaks, electrical hazards, loss of ventilation or respiratory support and risk of serious patient harm." - "before connecting to a patient, ensure the complete circuit functions correctly with required ventilator settings and appropriate ventilator or flow source alarms are set." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "check all connections are tight before use." - "to avoid damage to breathing tubes, attach and detach from equipment by handling end connectors only.Do not stretch, crush or twist tubing." additionally, the user instructions of 900mr782 reusable infant breathing circuit also includes the following reprocessing instructions warnings: - "clean product prior to use and whenever product is visibly soiled.Follow the reprocessing instructions (ui-623716).Alternative cleaning methods may deteriorate or damage the product, reducing the product life and compromising therapy." - "discard the product after 50 reprocessing cycles, or five years from the manufacturing date, whichever occurs earlier.".

Event Description

A distributor in germany reported via a fisher and paykel healthcare (f&p) field representative, that a 900mr782 reusable neonatal single heated breathing circuit was found damaged.There was no patient involvement.

• Brand Name: REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16989982
• MDR Text Key: 315840990
• Report Number: 9611451-2023-00487
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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: 900MR782
• Device Catalogue Number: 900MR782
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1