MAUDE Adverse Event Report: NEOPUFF INFANT RESUSCITATOR; BTL

Model Number	RD900
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently attempting to retrieve the complaint rd900 neopuff infant resuscitator for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that the outlet port of a rd900 neopuff infant resuscitator was broken.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) regional office in france, where it was inspected by a trained f&p service technician.Our investigation is thus based on the information provided by the f&p service technician.Results: visual inspection of the complaint rd900 neopuff infant resuscitator revealed that the gas outlet port was damaged.Conclusion: the most likely cause of the reported event is physical damage due to impact.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 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".Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications.Any unit that fails is rejected.The subject neopuff would have met the requirements at the time of production.
Event or Problem Description
A healthcare facility in france reported via a fisher and paykel healthcare (f&p) field representative that the outlet port of a rd900 neopuff infant resuscitator was broken.There was no patient involvement.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Common Device Name: BTL
• MDR Report Key: 10617519
• Report Number: 9611451-2020-00847
• Device Sequence Number: 11461360
• Product Code: BTL
• UDI-Device Identifier: 09420012410948
• UDI-Public: (01)09420012410948(10)2100751588(11)190415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K892885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RD900
• Device Catalogue Number: RD900
• Device Lot Number: 2100751588
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/04/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1