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

Model Number IW932AEK

Device Problems Crack (1135); Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw932 warmer head assembly was received at our fisher & paykel healthcare regional facility in (b)(4) where it was inspected by a trained fisher & paykel healthcare service technician.Our investigation is based on the photographs provided by the service centre.Results: visual inspection of the provided photographs revealed cracking and chipping of the upper head case.It is likely that the cracking and chipping 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 and chipping of the heater head.It must be noted that the complaint unit is over ten years old.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.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 complaint device was manufactured prior to the implementation of this measure.

Event Description

A hospital in (b)(6) reported that the heater head of an iw932 cosycot was cracked.There was no patient involvement.

• Brand Name: 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6867782
• MDR Text Key: 86634845
• Report Number: 9611451-2017-00856
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW932AEK
• Device Catalogue Number: IW932
• Device Lot Number: 051107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2005
• 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