MAUDE Adverse Event Report: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER; BTT

Model Number MR225

Device Problems Overfill (2404); Insufficient Information (3190)

Patient Problem Bradycardia (1751)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in progress of completing our investigation to determine if f&p'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 the (b)(4) reported that a mr225 manual fill humidification chamber was overfilled while using a water bag.It was noted that the water was in the breathing circuit and on the infant's face.The hospital reported that the infant was "bradycardic, mottled but well saturated".No further patient consequences were reported.

Event Description

A healthcare facility in the uk reported that a mr225 manual fill humidification chamber was overfilled while using a water bag.It was noted that the water was in the breathing circuit and on the infant's face.The hospital reported that the infant was "bradycardic, mottled but well saturated".No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the complaint mr225 manual fill humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Information regarding the use and set-up of the product was requested from the hospital, however no further information was made available.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the mr225 humidification chamber, which was connected to a water bag, overfilled during use.Conclusion: without the return of the complaint device and further information, we are unable to determine the root cause of the reported fault.Mr225 is a manually filled chamber and the water level is to be controlled by the operator or user.Further training on the use of the mr225 chamber was offered to the hospital staff.The user instructions that accompany the mr225 humidification chamber specify in the warning section: do not fill the chamber above the maximum fill level line.Liquid could enter the breathing circuit if the chamber is overfilled.Ensure that the water level in the chamber is periodically monitored.Refill when necessary.

• Brand Name: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 10480881
• MDR Text Key: 206385522
• Report Number: 9611451-2020-00750
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K913367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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: MR225
• Device Catalogue Number: MR225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 10/01/2020
• 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: Initial
• Patient Sequence Number: 1