MAUDE Adverse Event Report: REUSABLE HEATER WIRE; BTT

Model Number 900MR755

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).The complaint 900mr755 reusable heater wire is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine the involvement of our product in the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the 900mr755 reusable heater wire showed signs of burning near the top of a non-f&p water chamber.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr755 reusable heater wire was returned to fisher & paykel healthcare (f&p) where it was visually inspected and analysed.In addition, further testing was conducted to simulate the reported event using samples of the 900mr755 reusable heater wire.Results: visual inspection of the returned 900mr755 reusable heater wire showed blackened marks across the heater wire and the heater wire module.The returned device was further analysed using an electron microscope and scanning electron microscope analysis.Bubbles were observed within the wall section of the connector to the breathing circuit, which indicated resin degradation due to rapid heating.It was further observed that the chamber socket area was unaffected, and the charring was confined to one section.From the analysis, it was determined that the observed damage was likely due to the presence of external flammable materials.Further testing was conducted to confirm this hypothesis using a sample of the 900mr755 reusable heater wire.A fire was unable to be produced without the presence of external flammable materials.Conclusion: based on these findings, it is concluded that within the prescribed operating conditions, a fire could not be produced.We are unable to confirm the cause of the reported event.However, 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.Our user instructions for the mr850 respiratory humidifier state: · check accessories for damage before use and replace if damaged.· remove any sources of ignition, such as cigarettes, an open flame, or materials which burn or ignite easily at high oxygen concentrations.

Event Description

A distributor in germany reported via a fisher & paykel healthcare (f&p) field representative that the 900mr755 reusable heater wire showed signs of burning near the top of a non-f&p water chamber.There was no patient consequence.

• Brand Name: REUSABLE HEATER WIRE
• Type of Device: BTT
• MDR Report Key: 11572925
• MDR Text Key: 243520909
• Report Number: 9611451-2021-00300
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR755
• Device Catalogue Number: 900MR755
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 07/25/2021
• 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: DRAEGER BABYLOG 900 PLUS VENTILATOR; DRAEGER BABYLOG 900 PLUS VENTILATOR; DRAEGER TUBE SYSTEM; DRAEGER TUBE SYSTEM; F&P 900MR806 HEATER WIRE ADAPTOR; F&P 900MR806 HEATER WIRE ADAPTOR; F&P 900MR869 TEMPERATURE FLOW PROBE; F&P 900MR869 TEMPERATURE FLOW PROBE; F&P MR850 RESPIRATORY HUMIDIFIER; F&P MR850 RESPIRATORY HUMIDIFIER