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

Model Number MR810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) method: the complaint (b)(4) respiratory humidifier was not returned to fisher & paykel healthcare in (b)(6) for evaluation.Further information about the reported event was requested from the customer, however limited information was provided.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: a healthcare facility in (b)(6) reported via the nmpa reporting system that a patient became hypoxemic when they developed a mucus plug in the airway while using a (b)(4) respiratory humidifier.It was noted a "see manual" indicator was flashing on the device.There was no further patient consequence reported.Conclusion: without the complaint device, we were unable to determine the cause of the reported event.The see manual indicator is a feature that notifies the user to respond to a condition with the (b)(4).Ventilation therapy continues to be delivered to the patient when the see manual indicator is triggered.All (b)(4) respiratory humidifiers undergo functional testing during production to verify the proper functioning of the device.The subject (b)(4) respiratory humidifier would have met the required specification at the time of production.The user instructions accompanying the (b)(4) state the following: if the red light is illuminated, the humidifier and all accessories should be immediately removed and sent for servicing.

Event Description

A healthcare facility in (b)(6) reported via the nmpa reporting system that a patient became hypoxemic when they developed a mucus plug in the airway while using an mr810 respiratory humidifier.It was noted a "see manual" indicator was flashing on the mr810 respiratory humidifier.There was no further patient consequence reported.

• 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
• MDR Report Key: 12551082
• MDR Text Key: 274001401
• Report Number: 9611451-2021-01092
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012411044102
• UDI-Public: (01)09420012411044102(10)1173829(11)200626
• Combination Product (y/n): N
• PMA/PMN Number: K143646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR810
• Device Catalogue Number: MR810
• Device Lot Number: 2101173829
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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
• Patient Outcome(s): Other