MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BABY CONTROL MOBILE INFANT WARMER; FMT

Model Number IW910JEU

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint infant warmer head was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on photographs of the damaged warmer head and our knowledge of the product.Results: visual inspection of the provided photographs revealed multiple cracks on the upper head case as well as crazing in this area.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.We note that the subject warmer was manufactured in 2004 and iis more than 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, 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." we have since revised our cleaning instructions to recommend specific proprietary cleaning wipes.The hospital was sent a replacement upper head case and the iw910 mobile infant warmer head is currently being repaired by the hospital biomed and will be put back into service after passing the required electrical safety and performance tests.

Event Description

A hospital in (b)(6) reported via a distributor that the iw910jeu baby control mobile infant warmer needs a repair of the head case.Further information and photographs of the complaint infant warmer were received and a visual inspection of the photographs revealed that the infant warmer head case was found cracked.The reported event was observed before use on a patient.

• Brand Name: BABY CONTROL MOBILE 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: 6180000
• MDR Text Key: 62538163
• Report Number: 9611451-2016-00841
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910JEU
• Device Catalogue Number: IW910JEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2004
• 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