MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NEOPUFF INFANT RESUSCITATOR; BTL

Model Number RD900

Device Problems No Apparent Adverse Event (3189); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rd900 neopuff infant resuscitator is currently enroute to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that a rd900 neopuff infant resuscitator unit has an insufficient pressure output.This issue was observed during the annual check.There was no patient involvement.

Event Description

A healthcare facility in france reported that a rd900 neopuff infant resuscitator unit has an insufficient pressure output.This issue was obeserved during the annual check.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rd900 neopuff infant resuscitator was received at our fisher & paykel healthcare (f&p) regional office in france where it was inspected by a trained f&p technician.The unit was serviced and performance tested.Results: no fault was found with the complaint rd900 neopuff infant resuscitator - the device passed all performance tests.Conclusion: we are unable to determine what have caused the reported event, as the complaint unit passed all performance checks and was within specification.The neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infant until adequate spontaneous breathing occurs.Being a portable device, the neopuff can be susceptible to damage, for instance when accidentally dropped or subjected to considerable external force.The neopuff technical manual states the following: - dropping the neopuff 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.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Type of Device: BTL
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8167966
• MDR Text Key: 130494306
• Report Number: 9611451-2018-01077
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RD900
• Device Catalogue Number: RD900
• Device Lot Number: 141114
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1