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

Model Number IW910

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the complaint head case of the subject iw910jeu baby control mobile infant warmer from the hospital.We will provide a follow-up report once we have received the complaint head case and completed our investigation.

Event Description

A hospital in (b)(6) reported that the lower head casing of an iw910 mobile infant warmer was cracked.There was no patient involvement.

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: the photographs provided showed plastic shell flaking and chipping around the screw insertion hole.Crack lines were also apparent on the left and right side rails of the lower case.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 2005 and is almost 12 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.

Event Description

A hospital in (b)(6) reported that the lower head casing of an iw910 mobile infant warmer was cracked.There was no patient involvement.

• Brand Name: BABY CONTROL MOBILE INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7146250
• MDR Text Key: 95917129
• Report Number: 9611451-2017-01236
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW910
• Device Catalogue Number: IW910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2005
• 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