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).Method: the complaint iw910 mobile infant warmer wiring harness connector and heating element were not returned to fisher and paykel healthcare (fph) (b)(4).Our investigation is based on the photographs provided by the healthcare facility, our knowledge of the product and previous similar complaints.Results: visual inspection of the photographs revealed that the wiring harness connector was corroded, burnt and had broken off from the wiring harness.The spade terminal of the heating element was corroded.Conclusion: the reported e17 error code was most likely due to a discontinuity in power to the heater element.The damage observed to the housing connectors is possibly caused by poor connections between two electrical contacts, leading to contact failure.It must be noted that the subject warmer is 11 years old.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).Should the connectors completely fail during the operation, an audible and visual alarm will be registered on the front control panel of the infant warmer, thereby allowing the hospital staff time to act and provide other means of warming.The hospital was sent replacement parts and the subject iw910 mobile infant warmer will be repaired by the hospitals biomed.

Event Description

A hospital in washington reported that the connection between the wiring harness connector and heat element of the iw910 mobile infant warmer had melted and the infant warmer displayed an error code e17.There was no patient consequence.

• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6787234
• MDR Text Key: 83107603
• Report Number: 9611451-2017-00728
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971695
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 060821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2006
• 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