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

Model Number BC800

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint devices were not returned to fisher and paykel healthcare in (b)(4) for evaluation.Therefore, our investigation is based on information provided by the customer, previous investigations of similar complaints and our knowledge of the product.The customer reported that their bc800 series infant nasal masks were detaching from the flexitrunk tubing.Without the return of the complaint devices, we are unable to determine what may have caused the problem reported by the customer.If the complaint devices were returned, they would have been visually inspected for any damage.In addition,the dimensions would have been measured and compared to drawing specifications.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 (b)(6) reported via a fisher & paykel healthcare (fph) representative that their bc800 series infant nasal masks were dislodging from the flexitrunk nasal trunk tubing.No patient consequence was reported as no specific incident was reported.This was a general complaint reported by the hospital to an fph representative.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5690388
• MDR Text Key: 46253488
• Report Number: 9611451-2016-00239
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC800
• Device Catalogue Number: BC800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: FISHER & PAYKEL INFANT NASAL TUBING (FLEXITRUNK)