Manufacturer Confirms Concerns Regarding Pivot Securing Nut

Medical device manufacturer Fisher & Paykel Healthcare has issued a field safety notice related to concerns raised regarding its IW900 series Infant Warmer units, after concerns emerged in relation to a nut used on the systems.

There have been reports of breakage of the nut that secures the heater head on the unit, designed to assist the thermoregulation of infants weighing up to 10kg.

According to the company, the issue can cause the heater to detach partially and swing towards the bassinet – potentially putting a patient at risk.

Fisher & Paykel Healthcare has outlined a list of the affected model numbers on its website and confirmed it is issuing a replacement pivot securing nut to all affect customers.

Hospitals have been urged to identify any affected units in their inventory and contact the manufacturer if they are affected.

Expert Opinion

The problems which have emerged in relation to certain lot numbers of this product are clearly a major concern and it is vital that healthcare providers such as hospitals work quickly to identify if they have affected products which may need attention. <br/> <br/>"It is also vital that Fisher & Paykel Healthcare take steps to thoroughly investigate how such as fault has emerged, as well as what steps can be taken to ensure such problems are avoided again in the future. Many parents of young children will be concerned by these reports and everything should be done to put patient safety first." Kevin Timms - Solicitor