MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT NASAL MASK; BYG

Model Number BC802

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint bc802 infant nasal mask is currently en route to fisher & paykel healthcare (b)(4) for further investigation.We will provide a follow up report upon the completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that the bc802 infant nasal mask was becoming detached from the flexitrunk infant nasal tubing.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint bc802 infant nasal mask and bc192 flexitrunk were returned to fisher & paykel healthcare new zealand where they were inspected by trained f&p personnel.The nasal mask and the nasal tubing's midline cannula housing carrier dimensions were measured.Results: all measurements were within specification as per the part's respective drawings.Conclusion: the reported fault of the nasal mask becoming detached from the flexitrunk could not be confirmed.No fault was found with the returned devices.The user instructions that accompany the flexitrunk infant interface illustrate in pictorial format the correct set-up and proper use of infant interfaces, including the nasal mask and nasal tubing.It also states the following: "connect prongs and mask to nasal tubing ensuring that it is inserted fully." "if using mask: connect to patient by placing mask around the nose.The mask should sit comfortably around the patient's nose.It must not occlude the nostrils or touch the septum and should not be over the lip or over the eyes." "check that all circuit connections are tight before use and after any adjustment.".

Event Description

A hospital in australia reported via a fisher & paykel healthcare (f&p) representative that the bc802 infant nasal mask was becoming detached from the flexitrunk infant nasal tubing.No patient consequence was reported.

• Brand Name: INFANT NASAL MASK
• Type of Device: BYG
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8694097
• MDR Text Key: 147883283
• Report Number: 9611451-2019-00578
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC802
• Device Catalogue Number: BC802
• Device Lot Number: 2100717723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1