MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED BABY CONTROL MOBILE INFANT WARMER; FMT

Model Number IW910

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The head harness connector of the iw910 mobile infant warmer, which was reported to be discoloured, was not returned to fisher & paykel healthcare (fph) for investigation.Our analysis is accordingly based on our previous investigations on similar complaints, our knowledge of the product and a photograph provided by the customer.The upper and lower head harnesses are used to connect the head unit to the control unit of the infant warmer.Previous investigations on similar complaints revealed that the discoloration was most likely due to poor electrical contact caused by the degradation of the harness connectors.This degradation is likely a result of swivelling of the warmer head.It should be noted that the subject infant warmer unit was 10 years old at the time of the reported malfunction and a reasonable level of wear and tear is expected.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by (b)(4).The entire harness is enclosed in a ul v-0 rated fire retardant enclosure.Should the connectors completely fail, the infant warmer displays an error code and enters a fail safe 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.The infant warmer technical/service manual also contains a checklist which specifies that users perform safety, performance, and functional checks at least once a year.

Event Description

A hospital in (b)(6) reported that the "heater element end that connects to the heater wire connection is discoloured" of an iw910 mobile infant warmer.There was no patient involvement.

• Brand Name: BABY CONTROL MOBILE INFANT WARMER
• Type of Device: FMT
• 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 drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7975589
• MDR Text Key: 124980091
• Report Number: 9611451-2018-00887
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910
• Device Catalogue Number: IW910
• Device Lot Number: 050216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1