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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT Back to Search Results
Model Number MR850
Device Problems Break (1069); Mechanical Problem (1384); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
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 investigation.
 
Event Description
A healthcare facility in florida reported that a power cord of the mr850 respiratory heated humidifier was damaged with exposed copper wires.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr850 respiratory humidifier power cord was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected.Results: visual inspection of the returned power cord revealed a deep cut on the outer protective sleeve, however, no copper wires were found exposed.Conclusion: we are unable to determine the cause of the observed damage.However, it is likely due to physical damage.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 complaint with the following electrical standards: as/nzs 3200.1.0, can/csa 22.2 no.601.01, ul 60601-1, iec 60601-1.
 
Event Description
A healthcare facility in florida reported that a power cord of the mr850 respiratory heated humidifier was damaged with exposed copper wires.There was no patient involvement.
 
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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
17400 laguna canyon drive
suite 300
irvine, CA 92618
9194534000
MDR Report Key14691898
MDR Text Key297232037
Report Number9611451-2022-00535
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/17/2022
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 NumberMR850
Device Catalogue NumberMR850
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/17/2022
Initial Date FDA Received06/15/2022
Supplement Dates Manufacturer Received07/01/2022
Supplement Dates FDA Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2015
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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