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

Model Number MR850

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an mr850 respiratory humidifier was being used with an unheated inca cpap circuit and prongs.The rt left the temperature/flow probe connected and "wrapped" to the humidifier.The device then reached a temperature which reportedly gave a baby a burn on the nose.The probe was connected to the humidifier but not to the circuit.Upon following up with the respiratory therapist from the hospital, we were informed that the baby had already been discharged and was 'fine', having suffered no after-effects.

Manufacturer Narrative

(b)(4).The complaint mr850 humidifier was not returned to fisher & paykel healthcare (fph) as it is still in service at the hospital.Questions were sent to the hospital and our investigation is based on the information provided, along with our knowledge of the product.A lot check was unable to be performed as the serial number of the subject humidifier was not provided.Conclusion: user error in the set-up of a mr850 humidifier and accessories is likely to be the cause of the reported event.The customer has reported to us that the temperature probes were not inserted into the breathing circuit instead they were wrapped around the humidifier.On start-up, and during rapid changes in temperature, the humidifier tests to see if a probe is in place by cooling and then heating the probe.If the humidifier finds that either probe is not inserted into the breathing circuit, an alarm will be generated and the humidifier will enter stand-by.The user instructions that we provide with the mr850 humidifier include the following warning: -ensure that both temperature probe sensors are correctly and securely fitted.Failure to do so may result in temperatures in excess of 41°c being delivered to the patient.In this case the subject humidifier was set up with non-fph accessories, namely an inca brand cpap circuit and prongs.Fph only recommends the use of fph circuits with our humidifiers.The warning contained in our user instructions and printed on fph humidifiers states the following: "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance and compromise safety.The hospital has confirmed that the baby suffered no ongoing consequences as a result of this incident.

• 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: 3819569
• MDR Text Key: 4393457
• Report Number: 9611451-2014-00430
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 TEMPERATURE FLOW PROBE