(b)(4).Method: the complaint rd900 neopuff infant resuscitator was returned to the f&p regional office in germany where it was inspected by a trained f&p service technician.Our investigation is based on the service report provided by the f&p service technician.Results: visual inspection by the service technician confirmed that the gas outlet port of the subject neopuff was broken.Conclusion: the neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infants until adequate spontaneous breathing occurs.Being a portable device, the neopuff can be susceptible to impact damage, for instance when accidentally dropped or subjected to considerable external force.The neopuff technical manual warns against dropping the neopuff or subjecting it to impact damage which may cause the unit to operate incorrectly.If the neopuff is suspected to have been damaged, the manometer and valve system should be performance tested.The neopuff technical manual states the following: dropping the neopuff / perivent infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit.If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient.The subject neopuff was repaired at our service center and returned to the healthcare facility after passing the performance checks specified in the neopuff technical manual.
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