MAUDE Adverse Event Report: SERVO CONTROLLED HEATED RESPIRATORY HUMIDIFIER; BTT

Model Number HC500

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint hc500 humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare (f&p) field representative that during routine servicing, a hc500 humidifier was found to have a damaged power cord with exposed copper wires.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint hc500 humidifier was returned to the fisher & paykel healthcare (f&p) service center in california where it was inspected by a trained f&p technician.Our investigation is thus based on the information provided by our service centre.Results: visual inspection of the power cord revealed that it was damaged.Conclusion: based on the information, we are unable to determine what caused the reported fault.It should be noted that the subject device is over 11 years old.The hc500 humidifier is designed to the electrical safety standards, iec601-1 and as/nzs 3200.1.The materials used in the thermoplastic components of the mains connector and the cases are flame retardant according to iec601-1 and as/nzs 3200.1.Our user instructions that accompany the hc500 humidifier state the following: "never operate the hc500 if it has a damaged power cord or plug." "never operate the hc500 if any part of the hc500 is dropped or damaged or dropped into water." "do not attempt to repair or replace the power cord or plug without guidance from a qualified electrician or technician.".

Event Description

A distributor in florida reported via a fisher & paykel healthcare (f&p) field representative that during routine servicing, a hc500 humidifier was found to have a damaged power cord with exposed copper wires.There was no patient involvement.

• Brand Name: SERVO CONTROLLED HEATED RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 11030703
• MDR Text Key: 223732807
• Report Number: 9611451-2020-01170
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HC500
• Device Catalogue Number: HC500
• Device Lot Number: 100914
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2010
• 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