MAUDE Adverse Event Report: NEOPUFF INFANT RESUSCITATOR; BTL

Model Number RD900

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Ps343374.The complaint rd900 neopuff infant resuscitator is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the gas outlet port of a rd900 neopuff infant resuscitator was broken.It was also noted that the unit appeared to be dropped due to visible external damage.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the rd900 neopuff infant resuscitator was returned to the fisher & paykel healthcare (f&p) service center in irvine, where it was inspected by a trained f&p service technician.Additional information was later provided by the customer.Our investigation is thus based on the information provided by the f&p service technician and the customer.Results: visual inspection of the complaint rd900 neopuff infant resuscitator revealed that the gas outlet port was damaged and the manometer was out of specification.The customer also reported that the unit was dropped during cleaning.Conclusion: the reported damage was most likely caused by physical damage.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 can be susceptible to damage, for instance when accidentally dropped or subjected to considerable external force.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.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.

Event Description

A healthcare facility in florida reported that the gas outlet port of a rd900 neopuff infant resuscitator was broken.It was also noted that the unit appeared to be dropped due to visible external damage.There was no reported patient involvement.

• Brand Name: NEOPUFF INFANT RESUSCITATOR
• Type of Device: BTL
• MDR Report Key: 10310712
• MDR Text Key: 203494242
• Report Number: 9611451-2020-00627
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: 060706
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1