(b)(4). Method:the subject rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) in (b)(4) where it was visually inspected and performance checked by a trained f&p service technician. Results: inspection of the subject neopuff revealed that the manometer and valve was non operational. Conclusion: we are unable to determine what may have caused the reported event. The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to an infant until adequate spontaneous breathing occurs. Being a portable device, 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. In addition the neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff". The neopuff is assembled and 100% tested on the production line to verify that each neopuff product conforms to critical product specifications. All neopuffs are visually inspected and performance tested prior to leaving the production line, and those that fail are rejected. It should be noted that the subject device is over 12 years old.
Patient Sequence No: 1, Text Type: N, H10
A healthcare facility in (b)(6) requested a routine service for a rd900 neopuff infant resuscitator. Upon device assessment at the fisher & paykel healthcare (f&p) regional office in (b)(4) on the 2nd of march 2020, it was found that manometer and valve were faulty. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5