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

Model Number IW932AFU

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw932 baby controlled cosy cost infant warmer was received at the fisher & paykel healthcare (fph) office in (b)(4) where it was inspected by a trained fph service engineer.The power pcb board and supercapacitor of the complaint infant warmer was sent to fph (b)(4) for investigation.The pcb board was performance tested by inserting it into a working infant warmer unit.Results: when power was applied, the test infant warmer powered up and worked normally; however, the power fail alarm did not operate when the power at the supply wall outlet was switched off.Continuity testing of the supercapacitor on the power pcb board revealed that the connection of the supercap terminal was open circuit.Conclusion: we also note that the subject infant warmer is approximately 14 years old.The supercapacitor is a replaceable component of the power pcb.The supercapacitor'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.Based on our investigation, it is most likely that the power pcb board was damaged during the removal of the previous supercapacitor causing the power failure alarm.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 fitted with a new power pcb and returned to hospital service after passing the required safety and performance checks.

Event Description

A hospital in (b)(6) reported that the power alarm of an iw932 did not work.There was no reported patient involvement.

• Brand Name: COSYCOT 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: irfanali kermalli ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6746226
• MDR Text Key: 81143445
• Report Number: 9611451-2017-00665
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW932AFU
• Device Catalogue Number: IW932
• Device Lot Number: 040227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2004
• 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