MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD IW930 COSYCOT INFANT WARMER; FMT

Model Number IW930

Device Problems Crack (1135); Failure to Read Input Signal (1581); Device Displays Incorrect Message (2591); Connection Problem (2900); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint iw930 cosycot infant warmer is expected, but has not yet been returned to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it had a malfunction which caused or contributed to the reported event.We will submit a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel heathcare field representative that the head of an iw930 cosycot infant warmer was cracked and had slight heat damage.It was also reported that the complaint infant warmert would not go up or down with the buttons and that it produced an error e17.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint iw930 cosycot infant warmer was not returned to f&p in new zealand for investigation.Our investigation is thus based on the information and photographs provided by the customer, our knowledge of the product and previous investigations into similar complaints.Results: visual inspection of the photographs provided showed crazing on the dome portion of the head with cracked lines developed on the area as well as slight dicolouration of the plastic.The photographs also showed that the heating element terminals were corroded and the nomex insulation surrounding the heating element terminals appeared to be heat damaged.Conclusion: it is likely that the crazing and cracking observed on the infant warmer head are related to a known problem of incompatible cleaning solutions reacting with the polycarbonate plastic and acrylic components of the infant warmer.When the infant warmer head begins to warm up during use, a chemical reaction with the incompatible cleaning solution results in gradual cracking and crazing of the infant warmer head.Previous similar complaints have shown that the degradation of the heater element is usually the result of normal aging failure.Possible loss of electrical contact due to degradation of the heating element or harness connector will result in an error 17 condition.This type of failure will trigger an audible and visual alarm to warn the user of a malfunction in the infant warmer.The subject infant warmer is almost 14 years old and a reasonable level of wear and tear is expected.All components on the harness assembly of the infant warmer are enclosed in a sheath and fire rated by underwriters laboratories (ul).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.The customer elected to repair the subject infant warmer.This will be conducted by a trained biomedical engineer.

Event Description

A hospital in colorado reported via a fisher & paykel heathcare field representative that the head of an iw930 cosycot infant warmer was cracked and had slight heat damage.It was also reported that the complaint infant warmert would not go up or down with the buttons and that it produced an error e17.No patient consequence was reported.

• Brand Name: IW930 COSYCOT INFANT WARMER
• Type of Device: FMT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7343827
• MDR Text Key: 102754844
• Report Number: 9611451-2018-00202
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K971695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW930
• Device Catalogue Number: IW930
• Device Lot Number: 040517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1