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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT
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RESPIRATORY HUMIDIFIER; BTT Back to Search Results
Model Number MR850
Device Problems Defective Component (2292); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint mr850 respiratory humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported that the power cord of a mr850 respiratory humidifier was damaged.There was no reported patient consequence.
 
Event Description
A healthcare facility in florida reported that the power cord of a mr850 respiratory humidifier was damaged.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr850 respiratory humidifier was returned to our fisher & paykel healthcare (f&p) service centre in california where it was inspected by a trained f&p service technician.Results: visual inspection revealed that the power cord was damaged however, no copper wires were exposed.Conclusion: we are unable to determine what caused the reported failure.During production the electrical connections of the earth wires on all mr850 units are 100% tested for electrical continuity.Any product that fails is rejected.All mr850 units are visually inspected for damaged power cords before release for distribution.This suggests that the damage occurred after it had been distributed.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking, performance and electrical safety testing of the mr850 heater base.In addition, the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 respiratory humidifier is compliant with the following electrical standards: as/nzs 3200.1.0, can/csa 22.2 no.601.01, ul 60601-1, iec 60601-1.
 
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Brand Name
RESPIRATORY HUMIDIFIER
Type of Device
BTT
MDR Report Key11446901
MDR Text Key240366292
Report Number9611451-2021-00261
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMR850
Device Catalogue NumberMR850
Device Lot Number090526
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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