MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED 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).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.(b)(4).

Event Description

A hospital in (b)(6) reported that the top head case of an iw910jeu baby control mobile infant warmer was cracked.This was observed before use on a patient.

Manufacturer Narrative

(b)(4).The warmer head assembly of the complaint iw910jeu baby control mobile infant warmer was not returned to fph for investigation.Attempts were made to obtain the subject warmer head assembly but no response was received from the hospital.Our analysis is accordingly based on the results of our previous investigations on similar complaints, and our knowledge of the product.Based on the results of our previous investigations on similar complaints, it is likely that the reported cracking 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 warmer head begins to warm up during use, a chemical reaction with the incompatible cleaning solution results in gradual cracking and crazing of the warmer head.The product technical manual of the infant warmer features a diagram of the infant warmer which highlights the plastic surfaces of the unit containing components made from polycarbonate or acrylic, and states the following: "caution do not clean the highlighted plastic surfaces with proprietary cleaning products containing 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 products.

Event Description

A hospital in (b)(6) reported that the top head case of an iw910jeu baby control mobile infant warmer was cracked.This was observed before use on a patient.

• 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: raymond yan ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6128246
• MDR Text Key: 60906460
• Report Number: 9611451-2016-00811
• 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: 11/01/2016

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: IW910JEU
• Device Catalogue Number: IW910JEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2005
• 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