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

Model Number MR850

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/09/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an mr850 respiratory humidifier heated up to 41°c and did not alarm.They further reported that a patient developed a 1-2 grade scalding on the bridge of the nose.The hospital used an intersurgical tubing system without an extension.The hospital further reported that the patient's status was normal.

Manufacturer Narrative

(b)(4).Our investigation is currently in progress.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was not returned to fisher & paykel healthcare for evaluation.Therefore, our investigation is based on the information provided by the hospital and our knowledge of the mr850.Results: the complaint mr850 respiratory humidifier was tested by the hospital technician who confirmed that the mr850 passed the performance check with no issues.No fault was found with the complaint mr850.Further information provided by the hospital revealed that an intersurgical breathing circuit and medijet 1000 interface were used with the mr850 at the time of the reported event.Also, the reported injury was on the bridge of the patient's nose and no injury was noted around the patient's nares.Conclusion: based on the information provided by the hospital the reported injury may have been caused by the setup and use of the interface which is not manufactured by fisher & paykel healthcare.Fisher & paykel healthcare does not recommend using third party components such as intersurgical breathing circuits with the mr850.The below warning is included in the mr850 user instructions and is also printed on the mr850."the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety." the mr850 respiratory humidifier also complies with iso-8185 respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems.This standard contains several requirments relating to the safety and performance of respiratory humidification systems.To prevent thermal injury, the standard also includes maximum enthalpy limits for humidified gas delivered through respiratory humidification systems.No fault was found with the mr850 during the performance check.This suggests that the mr850 functioned as expected and did not contribute to the reported injury.

Event Description

A hospital in (b)(6) reported that an mr850 respiratory humidifier heated up to 41°c and did not alarm.They further reported that a patient developed a 1-2 grade scalding on the bridge of the nose.The hospital used an intersurgical tubing system without an extension.The hospital further reported that the patient's status was normal.

• 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 ; 9494534000
• MDR Report Key: 4070662
• MDR Text Key: 4896537
• Report Number: 9611451-2014-00754
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2014

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: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2014
• Initial Date FDA Received: 09/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTERSUGICAL TUBING SYSTEM