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

Model Number IW920

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a iw920 mobile infant warmer power fail alarm was not working.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint iw910 infant warmer was evaluated by a trained f&p service technician at our service centre in germany.Results: during testing it was noted that the unit's power fail alarm did not function when the unit was disconnected from power.Visual inspections also revealed that the upper head case was cracked.Conclusion: without the complaint device, the cause of the reported event can not be conclusively determined.However, based on our knowledge of the product and the failure mode, it is likely that the replaceable super capacitor on the pcb board has 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.The observed damage on the warmer head is likely related to a known problem of incompatible cleaning solutions reacting with the polycarbonate plastic and acrylic components of the infant warmer.When the heater head begins to warm up during use a chemical reaction with the incompatible cleaning solution results in gradual crazing and cracking of the heater head.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 infant warmer service manual for the affected unit features a diagram of the infant warmer which highlights polycarbonate and acrylic components and states the following: "caution do not clean the highlighted plastic surfaces with proprietary cleaning products containing either hydroxides, hypochlorites, peroxides, gluteraldehyde or cleaning products with a greater than 30% alcohol base" "caution the chemicals used in these proprietary cleaning products may lead to discolouration, crazing and eventual cracking of the highlighted plastic surfaces." it should be noted that the device was manufactured in 2001 and is therefore more than 18 years old.

Event Description

A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative that a iw920 mobile infant warmer power fail alarm was not working.There was no reported patient involvement.

• Brand Name: MOBILE 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: 9276447
• MDR Text Key: 178562864
• Report Number: 9611451-2019-01056
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K970432
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW920
• Device Catalogue Number: IW920
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1