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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER
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FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER Back to Search Results
Model Number MR290V
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2014
Event Type  malfunction  
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an mr850 humidifier displayed 46 degrees celsius and that two mr290 humidification chambers had deformed.No patient consequence was reported.
 
Manufacturer Narrative
(b)(4).Fisher & paykel healthcare is still trying to obtain further information and the complaint devices for evaluation.We will provide a follow up report upon completion of our investigation.
 
Manufacturer Narrative
(b)(4).The complaint mr290 chamber was received for evaluation.In addition, other devices involved in the set-up were received: mr850 humidifier, serial number 120918156162, manufactured 18 sep 2012; 900mr805 heater wire adaptor, lot 090716, manufactured 16 july 2009; 900mr869 temperature probe, lot 110907 manufactured 7 sep 2011.These devices were all visually inspected and performance tested to check for malfunctions.Visual inspection of the complaint devices: both the chamber ports on the returned mr290 were deformed.No stress marks or cracks were found around the deformed ports.Upon visual examination no defect or damage was noted to the returned humidifier, heater wire adaptor or temperature probe.Performance test results: mr850 humidifier: the returned mr850 was performance tested using a known working circuit and chamber and left to run for 48 hours.No alarms or faults were noted during the test period.The mr850 also passed all performance and calibration tests as per the product technical manual.Both the heater wire adaptor and the temperature probe functioned normally when tested.Conclusion: further information received from the hospital revealed that the subject mr290 chamber had run dry prior to the observed deformation.They further confirmed that the mr850 had sounded an alarm to alert them of this issue.The deformation of the chamber likey occurred due to excessive heat in the chamber caused by loss of humidity once the chamber ran dry.Deformation would only occur if the chamber had been allowed continue operation for a prolonged period of time with no humidity.When the chamber runs out of water the mr850 displays a visual and audible alarm to alert the caregiver so that the water bag can be replaced.Our user instructions that accompany the mr290 chamber state: ensure there is a water supply connected to the chamber and that water is present within the chamber.
 
Event Description
A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an mr850 humidifier displayed 46 degrees celsius and that two mr290 humidification chambers had deformed.No patient consequence was reported.
 
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Brand Name
VENTED 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
raymond yan
15365 barranca parkway
irvine, CA 92618-2216
9494534000
MDR Report Key3707450
MDR Text Key19301045
Report Number9611451-2014-00268
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K934140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2014
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 Number1305300392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2013
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
FISHER & PAYKEL 900MR869 TEMPERATURE PROBE; FISHER & PAYKEL MR850 HUMIDIFIER; FISHER & PAYKEL RT280 BREATHING CIRCUIT KIT; FISHER & PAYKEL MR850 HUMIDIFIER; FISHER & PAYKEL RT280 BREATHING CIRCUIT KIT; FISHER & PAYKEL 900MR805 HEATER WIRE ADAPTOR
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