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

Model Number MR850

Device Problems Melted (1385); Sparking (2595)

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

Event Date 07/20/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that while using an mr850 respiratory humidifier they saw a spark and the patient circuit began to melt.They immediately disconnected the patient, who was unharmed.They further reported that the temperature sensor, humidification chamber and breathing circuit were damaged.

Manufacturer Narrative

(b)(4).We are still trying to obtain further information and, if possible, the devices for our investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint devices were not returned to fisher & paykel healthcare (fph) for evaluation; however the mr850 humidifier was returned to our regional office in (b)(6), where it was inspected and performance tested for four hours by a trained fph service technician.In addition, photographs were provided of the complaint devices and were visually inspected.Additional information was also obtained from the customer.Results: mr850 performance testing: the mr850 passed all performance and calibration testing and no abnormalities were detected.Inspection of the photographs: visual inspection of the photographs showed evidence of fire damage in the form of melting and/or discolouration.Smoke damage in the form of black residue was observed in the distal end of the heater wire and elbow, around the outlet port of the mr340 chamber, around the heater wire connector terminals and around the chamber and flow probe sensor housing.The distal end of the breathing circuit was heat damaged and had become separated from the cuff, which was still attached to the heater wire elbow.Conclusion: there was no functional fault found with the subject mr850.The humidifier passed all calibration and performance checks.Based on the photographic evidence, it is most likely that the fire originated in the region where the reusable inspiratory tube was connected to the outlet port of the chamber.It was reported to us that the customer saw some sparks inside the tubing before it started to melt.This can happen if the insulation of a reusable heater wire is damaged and a short circuit occurs between the conducting wires.It is possible for the insulation of a reusable heater wire to be damaged, if proper care is not taken during its cleaning process.Our reusable heater wire assembly user i-instructions state: - before assembling, check the heater wire to ensure there is no damage to the insulation, particularly in the area of the loop and the connector.If there is any damage, do not use.Our user instructions for the mr850 humidifier state: - check accessories for damage before use and replace if damaged.This is the only complaint we have received for the 900mr755 reusable heater wire in the past three years.

Event Description

A hospital in (b)(6) reported via our distributor that while using an mr850 respiratory humidifier they saw a spark and the patient circuit began to melt.They immediately disconnected the patient, who was unharmed.They further reported that the temperature sensor, humidification chamber and breathing circuit were damaged.

• 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: 4019156
• MDR Text Key: 4692758
• Report Number: 9611451-2014-00718
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• 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: 130909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2013
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE MR340 CHAMBER; FISHER & PAYKEL (B)(4) TEMPERATURE PROBE