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

Model Number IW934

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw934 infant warmer was inspected at the hospital by a trained fph service technician from our service centre in (b)(4).Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.The root cause was identified to be the failure of a capacitor on the pcb board.Conclusion: the subject infant warmer was released for distribution in 2011.It is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is six 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.The reported malfunction was discovered during a maintenance check with no patient involvement.The infant warmer was repaired and a new capacitor was fitted to the pcb.The subject infant warmer was returned to the customer after passing all the necessary safety and performance tests.Repaired at regional office.

Event Description

A hospital in (b)(6) requested a performance check of an iw934 cosycot infant warmer.During assessment it was found that the power fail audio alarm had failed.There was no 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6571134
• MDR Text Key: 75329872
• Report Number: 9611451-2017-00435
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 111123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• 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