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

Model Number IW934

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw934 cosycot infant warmer device evaluation anticipated at fisher & paykel healthcare service centre in (b)(6) but not yet begun.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare field representative that the power fail audio alarm of an iw934 cosycot infant warmer had failed.There was no patient involvement.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare field representative that the power fail audio alarm of an iw934 cosycot infant warmer had failed.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint iw934 cosycot infant warmer was evaluated by a trained f&p technician at our service centre in the france.Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.This was due to the failure of a capacitor on the pcb board conclusion: based on previous investigation of similar complaints and our knowledge of the product, it is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is more than 13 years old.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.

• Brand Name: BABY CONTROL COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10797522
• MDR Text Key: 216688135
• Report Number: 9611451-2020-00988
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934
• Device Catalogue Number: IW934
• Device Lot Number: 070209
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1