Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290V
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint mr290v vented autofeed humidification chamber 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 distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found cracked and leaking water during patient use.There was no reported patient consequence.
 
Event Description
A distributor reported on behalf of a healthcare facility in japan, via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found cracked and leaking water during patient use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr290v chamber revealed multiple vertical crack lines were observed around the base flange below water level marking.Further testing showed that the rolled base thickness was found to be within specification.Conclusion: we are unable to determine what may have caused the crack of the complaint chamber dome.However our investigation indicates that the crack was most likely due to mechanical stress.The stress source is unknown.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure" - "do not use the chamber if the seals are not intact when received, or if it has been dropped.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VENTED AUTOFEED HUMIDIFICATION CHAMBER
Type of Device
AUTOFEED CHAMBER
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LIMITED
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key15848920
MDR Text Key304198054
Report Number9611451-2022-01091
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMR290V
Device Catalogue NumberMR290V
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/28/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT380 ADULT EVAQUA2 BREATHING CIRCUIT; PURITAN BENNETT¿ 980 VENTILATOR
-
-