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

Model Number IW910

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw910 mobile infant warmer was only recently returned to our service centre in irvine california.Once servicing is completed, we will conduct an investigation (based on the service report), to determine if the subject infant warmer had a malfunction which might have caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(4) reported that the head casing of an iw910 mobile infant warmer was damaged.It was also reported that the head harness connector was discoloured.Servicing of the unit was requested.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint iw910 mobile infant warmer was returned our service centre in (b)(4) where it was inspected by a trained fisher & paykel healthcare (fph) service engineer.The heating element and harness connectors were then returned to fisher & paykel healthcare in (b)(4) where they were visually inspected and the resistance of the heating element was measured.Our investigation is also based on the service report and photographs provided by our service centre.Results: visual inspection of the returned devices revealed that the heating element and harness connectors were discoloured.The resistance of the heating element was within specification.Visual inspection of the head casing photograph revealed that it was discoloured from heat.A lot check revealed no other complaints of this nature for lot 061220.Based on the lot number, the unit is approximately 10 years old.Conclusion: the upper and lower harnesses 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.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 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.Furthermore, the components of the harness assembly are wrapped in a fire retardant sheath, and the entire enclosure is made from fire retardant plastic.The damaged components on the complaint iw910 mobile infant warmer were replaced and the unit was returned to the customer after passing the necessary electrical safety and performance checks.

Event Description

A hospital in (b)(6) reported that the head casing of an iw910 mobile infant warmer was damaged.It was also reported that the head harness connector was discoloured.Servicing of the unit was requested.No patient consequence was reported.

• 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, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology dr. suite 100; irvine; 8007923912
• MDR Report Key: 6105067
• MDR Text Key: 60083797
• Report Number: 9611451-2016-00772
• 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,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• 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: 061220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2006
• 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