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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BABY CONTROL MOBILE INFANT WARMER FMT

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FISHER & PAYKEL HEALTHCARE LTD BABY CONTROL MOBILE INFANT WARMER FMT Back to Search Results
Model Number IW910
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Method: the complaint iw910 infant warmer was evaluated by a trained f&p 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: it is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is more than 10 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.
 
Event Description
A healthcare facility in (b)(6) requested a routine service for their iw910 baby control mobile infant warmer. During servicing, a fisher & paykel healthcare (f&p) service engineer observed that the power fail alarm was not working. There was no patient involvement.
 
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Brand NameBABY CONTROL MOBILE INFANT WARMER
Type of DeviceFMT
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
173 technology drive
suite 100
irvine, CA 92618
9494534000
MDR Report Key9573288
MDR Text Key182580263
Report Number9611451-2020-00020
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K970432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW910
Device Catalogue NumberIW910
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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