MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD IW930 COSYCOT INFANT WARMER; FMT

Model Number IW930

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw930 infant warmer was received at fisher & paykel healthcare (fph) office in (b)(4), where it was inspected by a trained fph technician.Details of the service findings were supplied to fph (b)(4).Results: during servicing at our (b)(4) office the power fail alarm was found to be faulty due to a failed c22 capacitor on the power board.Conclusion: the subject infant warmer unit is more than 11 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 infant warmer unit was repaired by replacement of the supercap and was returned to the customer after passing the necessary electrical safety and performance tests.

Event Description

A healthcare facility in (b)(6) requested a preventive maintenance check on an iw930 cosycot infant warmer.During servicing, a fisher & paykel healthcare technician observed that the power fail alarm of the subject infant warmer was faulty.No patient consequence was reported.

• Brand Name: IW930 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5339680
• MDR Text Key: 34885390
• Report Number: 9611451-2016-00001
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW930
• Device Catalogue Number: IW930
• Device Lot Number: 040227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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