• 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 LTD 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 LTD VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290VX
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2023
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in china that a mr290vx vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).The complaint mr290vx vented autofeed humidification chamber was returned to fisher & paykel healthcare (f&p) in (b(6) where it was visually inspected and analysed.Visual inspection of the returned mr290vx chamber revealed small cracks with a starburst pattern around the hinge bracket near base flange.The multiple cracks were seen leading away from the point of impact.A horizontal crack was seen propagated from the small cracks.No whitening or stress mark was observed at the crack area.The rolled base thickness was measured and found to be within specification.We are unable to determine the root cause of the chamber crack.However, our investigation indicates that the crack is most likely due to mechanical force.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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 mr290vx chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290vx vented autofeed humidification chamber state the following: - "do not soak, wash, or sterilize this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "do not use the chamber if the seals are not intact when received, or if it has been dropped." - "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.".
 
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 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 road
suite 300
irvine, CA 92618
9494534000
MDR Report Key16607066
MDR Text Key312308923
Report Number9611451-2023-00222
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012429728
UDI-Public(01)09420012429728(10)2101526372(11)210225(17)260225
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/23/2023
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 NumberMR290VX
Device Catalogue NumberMR290VX
Device Lot Number2101526372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/23/2023
Initial Date FDA Received03/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2021
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 RT380 ADULT EVAQUA2 BREATHING CIRCUIT
-
-