MAUDE Adverse Event Report: NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT; BZE

Model Number 950N60

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 950n60 neonatal bubble cpap dual heated circuit kit is not sold in the united states of america (usa), but is considered similar to products sold in the usa.The 510(k) for these products is k100011.The complaint (b)(4) neonatal bubble cpap dual heated circuit kit is currently en route to fisher and paykel healthcare (f&p) new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that the bubble cpap generator of the 950n60 neonatal bubble cpap dual heated circuit kit was not able to achieve consistent bubbling.It was further reported that a hole was found in at the top of the bubble cpap probe.There was no patient consequence.

Event Description

A healthcare facility in australia reported, via a fisher & paykel healthcare (f&p) field representative, that the bubble cpap generator of the 950n60 neonatal bubble cpap dual heated circuit kit was not able to achieve consistent bubbling.It was further reported that a hole was found at the top of the bubble cpap probe.There was no patient consequence.

Manufacturer Narrative

(b)(4).The 950n60 neonatal bubble cpap dual heated circuit kit is not sold in the united states of america (usa), but is considered similar to products sold in the usa.The 510(k) for these products is k100011.Method: the subject 950n60 neonatal bubble cpap dual heated circuit kit was returned to f&p in new zealand (nz) for investigation where it was visually inspected.Results: visual inspection of the returned circuit kit revealed that there was no physical damage.A hole was found on the bubble cpap probe.Conclusion: we are unable to determine what may have caused the reported event.However, the cause of the reported event is likely due to a moulding issue.The user instructions which accompany the 950n60 neonatal bubble cpap dual heated circuit kit state the following: "perform a pressure and leak test on the breathing system before connecting to a patient." "check all connections are tight before use." the user instructions also warn the user: "set appropriate ventilator or flow source alarms to monitor therapy delivery." "appropriate patient monitoring (e.G.Oxygen saturation) must be used at all times.Failure to monitor the patient (e.G.In the event of an interruption to gas flow) may result in serious harm or death.".

• Brand Name: NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT
• Type of Device: BZE
• MDR Report Key: 11406179
• MDR Text Key: 244404883
• Report Number: 9611451-2021-00234
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012454577
• UDI-Public: (01)09420012454577(10)2101340584(11)201015
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 950N60
• Device Catalogue Number: 950N60
• Device Lot Number: 2101340584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1