MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD REUSABLE HEATER WIRE; BTT

Model Number 900MR754

Device Problems Thermal Decomposition of Device (1071); Flare or Flash (2942)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor in india reported via a fisher & paykel healthcare (f&p) field representative that the 900mr754 reusable heater wire was found burnt during use.There was no reported patient consequence.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that the 900mr754 reusable heater wire was found burnt during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr754 reusable heater wire was returned to fisher & paykel healthcare (f&p) where it was visually inspected and analysed.Results: visual inspection of the returned 900mr754 reusable heater wire revealed that the heater wire was burnt and broken at wire end.It was also observed that some parts of wire insulation (silicon) and yarn core (polyester) were missing and believed to have burnt off.Further inspection revealed that one of the broken tips was in a ball shape which appears to be the result of it having melted under high temperature.Conclusion: we are unable to confirm the cause of the reported event.However based on our previous investigations of similar complaints, the observed damage was most likely due to the presence of external flammable materials during use.All heater wires are tested during production.Any heater wire that fails will be rejected and disposed of.The subject device would have met the required specifications at the time of release.It is noted in the user instructions that accompany the 900mr754 reusable heater wire that his accessory is intended for use in fisher & paykel healthcare 900mr780 neonatal reusable breathing circuits.Additionally, the user instructions advise the user as follows: "do not use breathing circuits, chambers, accessories, or combinations which are not approved by fisher & paykel healthcare"."wear and degradation of electrical connectors may affect the product performance.Inspect the product components between uses." "visually inspect the heater-wire before each use on a patient.Discard if faulty or if there is any sign of insulation deterioration such as cracks, tears, or damage.These may lead to electrical hazards and possible risk of serious patient harm"."clean the product prior to use and whenever it is visibly soiled.Follow the reprocessing instructions.Alternative cleaning methods may deteriorate or damage the product, reducing the product life and compromise therapy." - "discard the product after 50 reprocessing cycles, or five years from the date of manufacture, whichever occurs earlier".In addition, our user instructions for the mr850 respiratory humidifier also state the following: "the use of breathing circuits, chambers, other accessories or parts which are not approved by fisher & paykel healthcare may impair performance or compromise safety." "use of damaged components or accessories may impair the performance of this device or compromise safety." "remove any sources of ignition, such as cigarettes, an open flame, or materials which burn or ignite easily at high oxygen concentrations.".

• Brand Name: REUSABLE HEATER WIRE
• 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: 15117543
• MDR Text Key: 296762155
• Report Number: 9611451-2022-00674
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR754
• Device Catalogue Number: 900MR754
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER; MAQUET RE-USABLE CIRCUIT; MAQUET RE-USABLE CIRCUIT; MAQUET VENTILATOR; MAQUET VENTILATOR