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

Model Number MR810

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the subject mr810 respiratory humidifier was received by the fisher & paykel healthcare (fph) service centre in (b)(4) for servicing.The damaged power cord was then returned to fph in new zealand for evaluation and was visually inspected.Results: visual inspection revealed bite marks on the outer sleeve of the returned power cord.Conclusion: the presence of bite marks suggest that the power cord was damaged by rodents.During production the electrical connections of the earth wires on all mr810 units are 100% tested for electrical continuity.In addition, all mr810 units are visually inspected before release for distribution.This suggests that the reported damage occurred after the subject mr810 had been distributed.The mr810 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking, performance and electrical safety testing of the mr810 respiratory humidifier.In addition, the product technical manual also states that 'after servicing the humidifier should be electrically safety tested, and performance tested, to ensure correct operation'.The mr810 respiratory humidifier is compliant with electrical standards ul 60601-1, iec 60601-1, can/csa c22.2 no.601.1 the user instructions that accompany the mr810 respiratory humidifier state: -'visually inspect equipment for damage before use.' the damaged power cord was replaced by our service centre and the subject mr810 was returned to the customer after passing performance and safety checks.

Event Description

A healthcare facility in (b)(6) reported that their mr810 respiratory humidifier had a damaged power cord.Service was requested.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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: jon stevens ; 173 technology dr. suite 100; 8007923912
• MDR Report Key: 6488896
• MDR Text Key: 72664701
• Report Number: 9611451-2017-00327
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2017

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: Lay User/Patient
• Device Model Number: MR810
• Device Catalogue Number: MR810
• Device Lot Number: 161123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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