MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD IW930 COSYCOT INFANT WARMER; FMT

Model Number IW930

Device Problems Crack (1135); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the heater head assembly of the complaint iw930 infant warmer was received at our fisher & paykel healthcare (fph) office in (b)(4), where it was inspected by a trained fph technician.Photographs were supplied to fph (b)(4).Results: visual inspection of the supplied photographs revealed crack lines at the dome portion of the heater head and at the head label.Chipping and crazing was also noted on the heater head.The subject infant warmer was released for distribution on 4 november 2005 and is thus already a more than ten year old unit.Conclusion: it is likely that the crazing and 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 and crazing 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: "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 hospital in (b)(6) reported that an iw930 cosycot infant warmer had a cracked warmer head and requested that the unit be serviced.No patient consequence was reported.

• Brand Name: IW930 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5412073
• MDR Text Key: 37521826
• Report Number: 9611451-2016-00041
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW930
• Device Catalogue Number: IW930
• Device Lot Number: 051028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2005
• 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