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

Model Number IW910

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw910 mobile infant warmer was received at our fisher & paykel healthcare (f&p) service centre in (b)(4) and was visually inspected by a trained f&p technician.Our investigation is thus based on the information provided by our service centre in france.Results: during the service, the head case of the subject iw910 mobile infant warmer was found to be cracked.Conclusion: 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.It should be noted that the subject device is over 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, 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." the user manual for the iw910 mobile infant warmer states "ensure all warmer parts and accessories are checked before returning the device to service".The device technical/service manual contains a checklist which specifies that users perform safety, performance and functional checks at least once a year.

Event Description

A healthcare facility in (b)(6) reported of an issue with the iw910 mobile infant warmer.Upon device assessment at the fisher & paykel healthcare (f&p) regional office in (b)(4) , it was discovered that the head case was cracked.There was no patient involvement.

• Brand Name: 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 11382820
• MDR Text Key: 252165968
• Report Number: 9611451-2021-00221
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K970432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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
• Device Lot Number: 080530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2008
• 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