MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL CONTROLLED INFANT WARMER; FMT

Model Number IW990

Device Problem No Audible Alarm (1019)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw990 infant warmer was returned to fisher & paykel healthcare (f&p) service centre in (b)(4) for servicing.The complaint device was visually inspected by a trained f&p technician.Results: during the service, it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.The fault was traced to the failure of a capacitor on the pcb.Conclusion: the subject iw990 infant warmer was released for distribution in 2003 and thus is a 15 year old unit.It is likely that the replaceable super capacitor on the pcb wore out over time.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 including the power fail alarm 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.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the power fail alarm of the iw990 wall mount infant warmer was not working.There was no reported patient involvement.

• Brand Name: MANUAL CONTROLLED INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 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: 8234249
• MDR Text Key: 133222538
• Report Number: 9611451-2019-00014
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K971461
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990
• Device Catalogue Number: IW990
• Device Lot Number: 030827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2003
• 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