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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL CONTROLLED INFANT WARMER; FMT

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FISHER & PAYKEL HEALTHCARE LTD MANUAL CONTROLLED INFANT WARMER; FMT Back to Search Results
Model Number IW990
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Method: the complaint iw990 infant warmer was inspected by a trained fph service technician at our service centre in (b)(4).Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.The root cause was identified to be the failure of a capacitor on the pcb board.Conclusion: the subject infant warmer was released for distribution in 2002.It is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is 14 years old.The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution.The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks including the power fail alarm at least once a year.Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.The reported malfunction was discovered during a maintenance check with no patient involvement.The infant warmer was repaired and a new capacitor was fitted to the pcb.The infant warmer was returned to the customer after passing all the necessary safety and performance tests.
 
Event Description
A subcontractor in (b)(6) reported that while performing a service for a hospital it was found that the power failure alarm of an iw990 wall mount infant warmer was not working.
 
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Brand Name
MANUAL CONTROLLED INFANT WARMER
Type of Device
FMT
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
173 technology drive
suite 100
irvine, CA 92618
9494534000
MDR Report Key5811196
MDR Text Key50066908
Report Number9611451-2016-00343
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K971461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/22/2016
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 NumberIW990
Device Catalogue NumberIW990
Device Lot Number020110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2016
Initial Date FDA Received07/20/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/10/2002
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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