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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD MOBILE INFANT WARMER FMT Back to Search Results
Model Number IW920
Device Problems Device Alarm System (1012); No Audible Alarm (1019); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). We are currently in the process of investigation. We will provide a follow up report upon completion of investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a iw920 mobile infant warmer power fail alarm was not working. There was no reported patient involvement.
 
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Brand NameMOBILE 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 Key9276447
MDR Text Key178562864
Report Number9611451-2019-01056
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K970432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW920
Device Catalogue NumberIW920
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
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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