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

Model Number IW934

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint iw934 cosycot infant warmer is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported the iw934 cosycot infant warmer heating element was burnt on both the upper and lower harnesses.There was no patient consequence.

Event Description

A healthcare facility in washington reported the iw934 cosycot infant warmer heating element was burnt on both the upper and lower harnesses.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint iw934 cosycot infant warmer was not received at fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is thus based on the information and photograph provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the provided photograph showed discolouration of the upper head harness connector.The upper and lower head harnesses are used to connect the head unit to the control unit of the infant warmer.Conclusion.Based on the visual inspection we are unable to conclusively determine what may have caused the reported event.However, from previous investigations on similar complaints revealed that the discoloration was most likely due to poor electrical contact caused by the degradation of the harness connectors.This degradation is likely a result of swivelling of the warmer head.It should be noted that the subject infant warmer unit was more than fourteen years old at the time of the reported event 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 entire harness is enclosed in a ul v-0 rated fire retardant enclosure.Should the connectors completely fail, the infant warmer displays an error code and enters a fail-safe state where the heater element is disabled and the infant warmer alarms to allow the user to act and provide an alternate means of warming.The infant warmer technical/service manual also contains a checklist which specifies that users perform safety, performance, and functional checks at least once a year.The user instructions also state the following warnings: "all personnel must be familiar with the operation of this warmer before using the device with patients." "independent monitoring of temperature is essential for any baby under an infant radiant warmer.".

• Brand Name: 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: 10643761
• MDR Text Key: 211348875
• Report Number: 9611451-2020-00853
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IW934
• Device Catalogue Number: IW934
• Device Lot Number: 060407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1