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

Model Number MR850

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).We have requested further information to determine the involvement of the mr850 respiratory humidifier in regards 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 that a fisher & paykel healthcare (f&p) mr850 respiratory humidifier was taking 2 hours to heat up.It was also reported that the patient desaturated to 50% spo2 levels.No further patient consequences were reported.

Event Description

A healthcare facility in canada reported that a fisher & paykel healthcare (f&p) mr850 respiratory humidifier was taking 2 hours to heat up.It was also reported that the patient desaturated to 50% spo2 levels.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Method: the subject mr850 respiratory humidifier was returned to the fisher & paykel healthcare (f&p) in new zealand where it was functionally tested.Our investigation was based on the functional testing and the limited information provided by the customer.Results: the subject mr850 was subjected to an extensive soak test which revealed no alarm or functional fault noted.Thus, we were unable to duplicate the fault reported by the customer that the unit is taking 2 hours to heat up.Conclusion: the subject mr850 respiratory humidifier was found to operate normally and within specification during the performance check.We note that in this event, the humidifier was operating within the normal temperature range.The humidifier is used to warm and humidify gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or medical gases.The mr850 respiratory humidifier features an audible and visual alarm which alerts the user if the displayed temperature exceeds 41°c, or if the airway temperature exceeds 43°c and immediately disables the heater-wire and the heater-plate.During use, the mr850 also features a visual low temperature warning which alerts the user if the displayed temperature drops below 35.5°c for 25 seconds.This warning will alert the user that low humidity is being delivered to the patient.If the temperature continues to remain below 35.5°c, an audible alarm will also be activated.If during operation, the airway temperature decreases below 29.5 °c, a visible and audible low temperature alarm will be activated immediately.The mr850 also features a water out visual and audio alarm which will trigger if there is no water present in the water chamber.

• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 12876004
• MDR Text Key: 281269562
• Report Number: 9611451-2021-01344
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2100404528(11)180126
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 2100404528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/25/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• 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
• Patient Outcome(s): Other