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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD WALL MOUNT INFANT WARMER; FMT
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FISHER & PAYKEL HEALTHCARE LTD WALL MOUNT INFANT WARMER; FMT Back to Search Results
Model Number IW980
Device Problems Material Discolored (1170); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).We are still endeavouring to retrieve the harness connector.We will provide a follow up report upon completion of our investigation.
 
Event Description
A healthcare facility in kentucky reported that an iw980 wall mount infant warmer was displaying an e17 error code and that the heater element harness connectors were discoloured.This was found before patient use.
 
Manufacturer Narrative
(b)(4).Method: the heating element of the subject iw980 infant warmer was sent to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and the resistance of the heating element was measured.Results: visual inspection revealed that the harness connectors of the heating element were discoloured.The heating element resistance testing revealed that the heating element was open circuited.Conclusion: the upper and lower harness connectors are used to connect the head unit to the control unit of the infant warmer.Previous investigations of similar complaints revealed that the discoloured harness connectors of the infant warmers were most likely the result of arcing that occurred between two electrical contacts, leading to contact failure.The arcing was most likely caused by a poor connection.We note that the subject warmer is almost twelve years old.The warmer's controller continuously monitors the power delivered to the heating element.Should the connectors completely fail the infant warmer displays an error code and enters a failsafe state where the heater element is disabled and the infant warmer alarms to allow the user to act and provide an alternate means of warming.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).The entire harness is enclosed in a ul v-0 rated fire retardant enclosure.Replacement parts have been sent to the customer to replace the discoloured harness connectors.
 
Event Description
A healthcare facility in kentucky reported that an iw980 wall mount infant warmer was displaying an e17 error code and that the heater element harness connectors were discoloured.This was found before patient use.
 
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Brand Name
WALL MOUNT INFANT WARMER
Type of Device
FMT
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
MDR Report Key7500306
MDR Text Key108251497
Report Number9611451-2018-00368
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
PMA/PMN Number
K971461
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIW980
Device Catalogue NumberIW980
Device Lot Number061026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Was the Report Sent to FDA? No
Date Manufacturer Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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