MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ESON NASAL MASK

Model Number 400450

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint mask has not been returned to fisher and paykel for evaluation.As part of our investigation into this issue we have sent questions about the incident to the distributer that reported it as well as the hospital where it occured.After three attempts we have received no response.At this stage we have no information as to how the event occured or the current status of the patient.If more information becomes available we will provide a follow-up report.Eson masks are visually inspected during manufacturing and any defective products are discarded.

Event Description

A distributer in the usa reported that an 400450 eson nasal mask caused a laceration to a patient's forehead that required 10 stitches.

• Brand Name: ESON NASAL MASK
• Type of Device: NASAL MASK
• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7137041
• MDR Text Key: 95454388
• Report Number: 9611451-2017-01232
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400450
• Device Catalogue Number: 400450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2012
• 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
• Patient Outcome(s): Required Intervention