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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 Problems No Audible Alarm (1019); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint iw990 wall mount infant warmer is currently en route to fisher & paykel healthcare (f&p) for evaluation. We will provide a follow-up report upon completion of our investigation.
 
Event Description
A healthcare facility in the (b)(6) reported that the iw990 wall mount infant warmer speaker was not working. There was no reported patient consequence.
 
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Brand NameMANUAL CONTROLLED 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 Key11024797
MDR Text Key222300299
Report Number9611451-2020-01169
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,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW990
Device Catalogue NumberIW990
Device Lot Number120221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2012
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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