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

Model Number IW990

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw990 infant warmer was received at fisher & paykel healthcare (fph) office in the (b)(4), where it was inspected by a trained fph service engineer.The control and power pcb board 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.A lot check revealed no other complaint of this nature for the affected lot.Conclusion: the subject infant warmer unit is nearly 16 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 customer decided to purchase a new iw990 infant warmer and to discard the complaint unit, as the complaint unit is already 16 years old.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that the iw990 manual controlled infant warmer's power fail alarm did not work.A service has been requested.No patient consequence was reported.

• Brand Name: MANUAL CONTROLLED 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: 5665619
• MDR Text Key: 45472773
• Report Number: 9611451-2016-00222
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990
• Device Catalogue Number: IW990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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