MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED MANUAL CONTROL WALL MOUNT INFANT WARMER; FMT

Model Number IW990AFU

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the subject iw990afu manual control wall mount infant warmer was serviced by the fph subcontractor at the healthcare's facility.Our analysis is accordingly based on the information provided by the subcontractor and our knowledge of the product.Results: during servicing, it was noted that the unit did not pass the power fail alarm test.The root cause was identified to be the failure of a super capacitor on the pcb board.Conclusion: it is likely that the replaceable super capacitor on the pcb board has simply worn out as the unit is almost 10 years old.The super capacitor's function is to store sufficient electrical charge to power the infant 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 infat 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 infant warmer's maintenance checklist is a test of the super capacitor to ensure it is operating within specifications.The reported malfunction was discovered during the preventive maintenance check with no patient involvement.The infant warmer was repaired and a new capacitor was fitted to the pcb.The infant warmer was returned to the healthcare facility service after passing all the necessary safety and performance tests.

Event Description

A healthcare facility in (b)(6) requested a preventive maintenance check for their iw990afu manual control wall mount infant warmer.During servicing of the unit, which was conducted by a fisher & paykel healthcare (fph) servicing subcontractor in france, it was observed that the power fail alarm was not working.There was no patient involvement.

• Brand Name: MANUAL CONTROL WALL MOUNT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 7062394
• MDR Text Key: 93604463
• Report Number: 9611451-2017-01112
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990AFU
• Device Catalogue Number: IW990AFU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2008
• 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