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

Model Number IW910AEK

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: a routine service was carried out on the iw910aek baby control mobile infant warmer at the hospital facility by a trained fph service engineer.Our analysis is accordingly based on the service report provided by fph service engineer.Results: during servicing it was observed that the power fail alarm was not functioning, which was attributed to the super capacitor failure on the power pcb board.Conclusion: the subject infant warmer unit is more than 14 years old, and it is likely that the replaceable super capacitor on the pcb board had simply worn out.The super capacitor's function is to store sufficient electrical charge to power the warmer's visual and audible alarms in the event of a failure of mains power.Part of fisher & paykel healthcare's quality control process involves testing the power failure alarm of every warmer on the production line for functionality prior to distribution.The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks at least once a year.Included in the warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.The subject infant warmer was repaired, and returned to the hospital service after passing the performance checks and electrical safety tests specified in the product technical manual.

Event Description

A hospital in ireland requested a routine service for their iw910aek baby control mobile infant warmer.During servicing, a fisher & paykel healthcare (fph) service engineer observed that the power fail alarm was not working.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, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6793367
• MDR Text Key: 82673779
• Report Number: 9611451-2017-00740
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910AEK
• Device Catalogue Number: IW910AEK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2003
• 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