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

Model Number IW934

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw934 cosycot infant warmer head was returned to our fisher & paykel healthcare regional office in (b)(4) for evaluation where it was inspected by a trained technician.Results: visual inspections revealed the heater head case is cracked.Conclusion: based on our knowledge of the product and this failure mode, it is likely that the observed damage on the 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 crazing and cracking of the heater head.It must be noted that the complaint device is over twelve 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.".

Event Description

A healthcare facility in (b)(6) requested a routine service via a fisher & paykel healthcare (f&p) field representative, for a iw932 cosycot infant warmer.Upon device assessment at the fisher & paykel healthcare (f&p) regional office on the 25th october 2019, it was found that the head of iw934 cosycot infant warmer was cracked.There was no patient involvement.

• Brand Name: COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 9360033
• MDR Text Key: 178781740
• Report Number: 9611451-2019-01124
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971695
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934
• Device Catalogue Number: IW934
• Device Lot Number: 070209
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2007
• 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