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Safety warning from regulator on safety of baby warmers

Fisher and Paykel baby warmer identified as posing potential serious injury risk

Baby warmer risk

22 December 2014

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a medical device alert about the Fisher and Paykel Healthcare IW900-series infant warmer.

The MHRA has published this alert because the heater head on the warmer may partially detach because of a manufacturing fault where the nut securing the heater head may break.

This means that the heater head could swing down to where the baby lies, potentially causing a serious injury.

The warmer is used in maternity units, delivery rooms, and hospital nurseries to regulate the temperature of babies who weigh up to 10 kg.

Fisher and Paykel originally issues a Field Safety Notice on 13.11.14 about the manufacturing fault and offered to provide replacement nuts to any customers who were affected.

The fault is restricted to two batches of nuts and a list of the affected model numbers is included in the FSN. 

However, the manufacturers have not received enough replies from customer to be sure that this information has been received and acted upon. 

Staff using the infant warmers are advised to follow the advice in the original Field Safety Notice by checking the reference, serial and lot number of the warmer being used and then to contact the manufacturers on 01628 678 411 to request a replacement nut.

Medical device lawyer and Leigh Day partner Michelle Victor said:

“Neonatal units must act quickly and respond to the warning from the MHRA about the Fisher and Paykel baby warmer.

“Staff must order the replacement part identified by the manufacturer as being faulty as soon as possible to ensure that the hospital equipment they are using does not threaten the safety of the babies in their care.”

Information was correct at time of publishing. See terms and conditions for further details.

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