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

Model Number IW990

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw990 infant warmer was returned to fisher & paykel healthcare (f&p) service centre in (b)(6) where it was visually inspected by a trained f&p technician.Our investigation is therefore based on the photographs and information provided by f&p service centre in germany, and our investigations of previous similar complaints.Results: visual inspection of the subject infant warmer revealed that the head case of the infant warmer was found to be cracked.Conclusion: we are unable to determine the cause of the cracked infant warmer head.However it is most 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.The subject iw990 infant warmer is over 13 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." we have since revised our cleaning instructions to recommend specific proprietary cleaning wipes.The user manual for the iw990 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.The subject infant warmer was repaired and was returned to the customer after passing all the required safety and performance tests.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative, an issue with an iw990 infant warmer.Upon device servicing at the f&p regional office, it was discovered that the head case was cracked.There was no patient involvement.

• Brand Name: MANUAL CONTROLLED 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12550899
• MDR Text Key: 273993626
• Report Number: 9611451-2021-01110
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K971461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW990
• Device Catalogue Number: IW990
• Device Lot Number: 080721
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2008
• 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