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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED BABY CONTROL WALL MOUNT INFANT WARMER FMT

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FISHER & PAYKEL HEALTHCARE LIMITED BABY CONTROL WALL MOUNT INFANT WARMER FMT Back to Search Results
Model Number IW980
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Method: the complaint iw980 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 worn out. 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 of an iw980 wall mount infant warmer. Upon device assessment on the 20th february 2020, at the fisher & paykel healthcare (f&p) regional office in (b)(6), it was found that the power fail alarm was not working. There was no patient involvement.
 
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Brand NameBABY CONTROL WALL MOUNT INFANT WARMER
Type of DeviceFMT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LIMITED
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 dr.
suite 100
irvine, CA 92618
9494534000
MDR Report Key9851237
MDR Text Key184874890
Report Number9611451-2020-00288
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K971461
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 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW980
Device Catalogue NumberIW980
Device Lot Number150218
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2015
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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