MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Pressure Sores (2326)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).We are in the process of obtaining the complaint devices and further information from the customer for evaluation to determine if (b)(6) healthcare's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a (b)(6) healthcare field representative that "a patient had a burn or pressure sore around the patient's nose during the use of mr850 respiratory humidifier" after one day of use.There was no reported further patient consequence.

Event Description

A healthcare facility in japan reported via a fisher & paykel healthcare field representative that "a patient had a burn or pressure sore around the patient's nose during the use of mr850 respiratory humidifier" after one day of use.There was no reported further patient consequence.

Manufacturer Narrative

(b)(4).Correction: section b1 date of event updated to 18 dec 2019.Method: the complaint mr850 respiratory humidifier, the 900mr800 heater wire adaptor and the 900mr869 temperature probe were performance tested at fisher & paykel healthcare's regional office in japan and subsequently returned to fisher & paykel healthcare (f&p) in new zealand for investigation.We have also conducted a follow up visit to the hospital.Out investigation is based on the information provided by the hospital, device assessment and our knowledge of the product.Results: the hospital was unable to determine whether the reported injury was a burn or a pressure sore and advised that no medical or surgical intervention was required.Visual inspection of the mr850 respiratory humidifier, the 900mr800 heater wire adaptor and the 900mr869 temperature probe found that there was no damage observed on the any of the devices.The performance check at the japan regional office showed that there was no fault with the mr850 humidifier or the 900mr800 heater wire adaptor.A soak test performed at f&p nz using the three returned devices triggered repeat visual and audible alarms after 30 minutes of use.The soak test was repeated using a different mr850 and 900mr800 heater wire adaptor resulting in the same alarms being triggered.Further investigation of the 900mr869 temperature probe showed that it was outside of the specification.The complaint 900mr869 is 13 years old based on the date of manufacture.The hospital confirmed that regular maintenance outlined in the product technical manual and user instructions had not been performed on any of the returned devices.Conclusion: the hospital staff were unable to determine whether the reported injury was a burn or a pressure sore.Based on the information provided, we were unable to determine the cause of the reported event.The technical manual provided with mr850 respiratory humidifier states: ·"in order to keep your humidifier in good working order, it is necessary to perform maintenance at regular intervals." the technical manual also states that the heather wire adaptor and the mr850 should be checked annually while the temperature probe should be checked "every six months".The temperature probe maintenance requirement includes temperature and flow accuracy check.·"use of damaged components or accessories may impair the performance of this device or compromise safety." the user instructions which are provided with 900mr869 temperature probe states: ·"service life: 3 years, if used in accordance with this user instruction.Note: service life may vary depending on usage pattern." ·"probe maintenance and accuracy checks should be routinely performed.For further information, refer to the mr850 technical manual (available from your local fisher & paykel healthcare representative)." ·"failure to perform routine probe accuracy and visible damage checks may impair performance or compromise safety.".

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 9619559
• MDR Text Key: 176960711
• Report Number: 9611451-2020-00084
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2018
• 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: 900MR800 HEATERWIRE ADAPTOR; 900MR869 TEMPERATURE PROBE; CAREFUSION INFANT FLOW LP SYSTEM; F&P 900MR800 HEATERWIRE ADAPTOR; F&P 900MR869 TEMPERATURE PROBE; F&P RT132 BREATHING CIRCUITS; INFANT FLOW SIPAP; LP SYSTEM; VYAIRE MEDICAL INFANT FLOW SIPAP