MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

A healthcare facility in new york reported an issue with an mr850 respiratory humidifier.Upon device servicing at the regional office in california, it was identified that the power cord was damaged and the copper wires were visible and exposed.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was returned to our fisher & paykel (f&p) healthcare service centre in california where it was inspected by a trained f&p service technician.Results: visual inspection of the returned power cord identified that the power cord insulation was cut and the copper wires were visible and exposed.Conclusion: we are unable to determine the cause of the observed damage.However, it is likely due to physical damage during use.During production the electrical connections of the earth wires on all mr850 units are 100% tested for electrical continuity.Any product that fails is rejected.All mr850 units are visually inspected for damaged power cords before release for distribution.This suggests that the damage occurred after it had been distributed.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking, performance and electrical safety testing of the mr850 heater base.In addition, the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 respiratory humidifier is complaint with the following electrical standards: as/nzs 3200.1.0, can/csa 22.2 no.601.01, ul 60601-1, iec 60601-1.

• Brand Name: RESPIRATORY HUMIDIFIER
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18480925
• MDR Text Key: 332669848
• Report Number: 9611451-2024-00010
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2101501594(11)210209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/13/2023

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: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101501594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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