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U.S. Department of Health and Human Services

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

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FISHER & PAYKEL HEALTHCARE LIMITED WALL MOUNT INFANT WARMER FMT Back to Search Results
Model Number IW980
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Method: the complaint iw980 wall mount infant warmer was not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the information provided by the customer, previous investigations of similar complaints and our knowledge of the product. Results: the customer stated that the power fail alarm of a iw980 wall mount infant warmer was not working. Conclusion: without the complaint device, we are unable to determine the cause of the reported fault. We note that the complaint iw980 wall mount infant warmer is approximately 13 years old. Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every infant warmer 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 infant warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.
 
Event Description
A healthcare facility in (b)(6) reported that during a maintenance check the power fail alarm of a iw980 wall mount infant warmer was not working. There was no patient involvement.
 
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Brand NameWALL 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 Key11276786
MDR Text Key244832801
Report Number9611451-2021-00115
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIW980
Device Catalogue NumberIW980
Device Lot Number070707
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2007
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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