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

Model Number MR850

Device Problems Break (1069); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is awaiting service at the fisher & paykel healthcare (fph) regional office in (b)(4).Therefore our investigation is still in progress and we will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in usa reported that the power cord was damaged on a mr850 respiratory heated humidifier.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier's power cord was received at fisher & paykel healthcare in new zealand for further investigation.Results: visual inspection revealed that the insulation near the plug was damaged, however, there were no exposed wires accessible to the customer.Conclusion: from the investigation conducted, the nature of the damage observed on the power cord suggests impact damage from a sharp object.It should be noted that the subject mr850 was manufactured in 2010, indicating it would have been used for at least eight years before the cut occurred.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.

Event Description

A healthcare facility in usa reported that the power cord was damaged on a mr850 respiratory heated humidifier.No patient consequence was reported.

• 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
• MDR Report Key: 7239990
• MDR Text Key: 99356029
• Report Number: 9611451-2018-00087
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: 0109420012407290
• Combination Product (y/n): N
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2018
• 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: 100112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1