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

Model Number IW934

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining additional information from the customer, to determine if the complaint iw934 cosycot infant warmer had a malfunction which caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that an iw934 cosycot infant warmer had a cracked warmer head case.There was no patient involvement when the event was discovered.

Manufacturer Narrative

(b)(4).Method: the head uppercase of the complaint (b)(4) cosycot infant warmer was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Our investigation is based on the photograph provided by the hospital biomedical engineer and our knowledge of the product.Results: visual inspection of the photograph revealed chipped plastic along the middle bottom edge of the head uppercase.No cracking of the heater head was evident.A lot check revealed no other complaints of this nature for lot 070702.The subject infant warmer was released for distribution in 2007 and is a thus 10 year old unit.Conclusion: based on our knowledge of the product and this failure mode, it is likely that the physical damage to 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 crazing and 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: 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.We have since revised our cleaning instructions to recommend specific proprietary cleaning wipes.The hospital was sent a head upper case replacement part and will repair the subject infant warmer themselves.

Event Description

A hospital in (b)(6) reported that an (b)(4) cosycot infant warmer had a cracked warmer head case.There was no patient involvement when the event was discovered.

• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6150179
• MDR Text Key: 61592699
• Report Number: 9611451-2016-00834
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 070702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2007
• 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