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

Model Number MR850

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

A healthcare facility in (b)(6) reported that an mr850 humidifier has overheated while in use on a patient and the circuit showed signs of starting to melt.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the mr850 humidifier was not returned for evaluation, nor was the circuit that had reportedly started to melt.Questions were sent to the hospital in an attempt to discover more details about the sequence of events.We specifically asked about the device set-up and asked for a description of activities when the event occurred.We also requested a copy of the service report following the servicing of the device.We did not receive any additional photographs or other evidence of the reported damage.Our analysis is accordingly based on the description of events, the answers provided by the customer and our knowledge of the product.Conclusion: it was reported that the mr850 humidifier alarmed during use, while the humidifier displayed a temperature of 37 degrees celsius.The hospital staff activated the mute button to silence the alarm and restarted the humidifier.The mr850 then displayed a temperature of 41 degrees celsius.We note that 37 degrees celsius to 41 degrees celsius is the normal operating temperature range for the mr850.Based on this information, we were unable to confirm an overheating incident for the mr850 humidifier.More information was sought from the hospital regarding this incident, but the information we were able to obtain was not sufficient for us to determine what could have caused the incident as reported by the hospital.The interaction between the various components, namely the humidifier, the sensing probes, the chamber, the breathing circuit and the patient interface is critical to ensuring safe and efficacious delivery of therapy.If at a later date, we are able to obtain further information we will provide a follow up report.The mr850 has been sold worldwide for fifteen years.The mr850 complies with iso 8185:2007 'respiratory tract humidifiers for medical use - particular requirements for respiratory humidification systems'.This iso standard contains several guidelines relating to the safety and performance of respiratory humidification systems.The standard also specifies certain safety requirements to prevent the risk of thermal injury, including maximum enthalpy limits for humidified gas delivered to patients through respiratory humidification systems.

• 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: 4344164
• MDR Text Key: 5199085
• Report Number: 9611451-2014-00943
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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: 060510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2006
• 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 RT132 BREATHING CIRCUIT