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

Model Number IW990

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw990 infant warmer was returned to fisher & paykel healthcare service centre in (b)(4) for service.The complaint device was visually inspected by a trained f&p technician and photographs were provided to us for our investigation.Our investigation is based on the photographs and information provided by our service centre in germany.Results: during the service, 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.Service of the device also revealed that the head case of the infant warmer was cracked.Conclusion: the subject iw990 infant warmer was released for distribution in 2001 and thus is a 17 year old unit.It is likely that the replaceable super capacitor on the pcb board wore out over time.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.It is likely that the cracking of the complaint warmer head is 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 cracking of the heater head.The infant warmer service manual features a diagram of the infant warmer which highlights polycarbonate and acrylic components and states the following: - the plastic surfaces highlighted in black contain plastic components made from polycarbonate or acrylic, and include the entire heater assembly, bassinet side panels, column cap and front panel fascias.- caution do not clean the highlighted plastic surfaces with proprietary cleaning products containing either hydroxides, hypochlorites, peroxides, glutaraldehyde 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.As part of our continuous improvement initiatives on 2 june 2010 we changed the material used in the manufacture of the head housing to one that offers greater resistance to environmental stress cracking.We also revised our cleaning instructions to recommend specific proprietary cleaning wipes.The subject infant warmer was repaired and was returned to the customer after passing all the required safety and performance tests.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the power fail alarm of the iw990 wall mount infant warmer was not working.There was no patient involvement.

• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7684432
• MDR Text Key: 114018060
• Report Number: 9611451-2018-00598
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2001
• 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