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

Model Number MR850

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A distributor in (b)(4) reported that the power cord was damaged on a mr850 heated humidifier.This was found prior to patient use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was received at our regional office in (b)(4) where it was inspected by a trained fisher & paykel healthcare service engineer.Our investigation is accordingly based on photographs and servicing details provided by our (b)(4) office.Results: visual inspection of the photographs of the subject mr850 revealed that the power cord was cut.A lot check revealed no other complaints of damaged power cords for lot number 131023.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 2013, indicating it would have been used for at least a year 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.The damaged power cord was replaced and the device was returned to the customer after passing performance and safety checks.Repaired and returned to customer.

Event Description

A distributor in (b)(6) reported that the power cord was damaged on a mr850 heated humidifier.This was found prior to patient use.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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 5231916
• MDR Text Key: 31599622
• Report Number: 9611451-2015-00483
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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: 131023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• 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