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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LTD COSYCOT INFANT WARMER FMT Back to Search Results
Model Number IW934
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint iw934 cosycot infant warmer device evaluation anticipated at fisher & paykel healthcare service centre in (b)(6) but not yet begun. We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the power fail audio alarm of an iw934 cosycot infant warmer had failed. There was no patient involvement.
 
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Brand NameCOSYCOT 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 Key10796262
MDR Text Key216687833
Report Number9611451-2020-00987
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K971695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW934
Device Catalogue NumberIW934
Device Lot Number070209
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2007
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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