Medical device manufacturer, Covidien Private Limited issued a medical device safety alert concerning Puritan Bennett 840 Ventilator. The affected part number is4-070000-85 and the impacted software versions are AE to AK.
The manufacturer is conducting a voluntary field correction on Puritan Bennett 840 ventilator systems with certain software versions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error. The frequency of occurrence of this code is low, and in Asia,the manufacturerhas not received any reports related to this issue.
According to the manufacturer, the issue only impacts certain software versions. For those software versions, the two scenarios in which diagnostic code XB0069 can potentially occur are the following:
The manufacturer has developed a software solution to address this issue. Until the software is updated, users will need to remain vigilant regarding this issue.
The manufacturer advises users to always follow the instructions as described in the Puritan Bennett 840 Operator's Manual.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 16 December 2013