MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FLEXITRUNK INFANT INTERFACE HEADGEAR; BZO

Model Number BC325

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) product manager that an infant allegedly sustained a wound on the shoulder while using a bc325 flexitrunk infant interface headgear.It was also reported that no medical or surgical intervention was conducted and that infant was in good condition.

Manufacturer Narrative

(b)(4).The complaint bc325 flexitrunk infant interface headgear is not expected to be returned to fph for investigation.We are currently in the process of obtaining further information from the hospital in order to assist us with the analysis and identification of a possible root cause of the reported event.We will provide a follow up report once we have received further information and completed our analysis.

• Brand Name: FLEXITRUNK INFANT INTERFACE HEADGEAR
• Type of Device: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 3620941
• MDR Text Key: 20265663
• Report Number: 9611451-2014-00115
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC325
• Device Catalogue Number: BC325
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• 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: BC191 FLEXITRUNK INFANT INTERFACE NASAL TUBING; BC6060 FLEXITRUNK INFANT INTERFACE NASAL PRONGS; BC802 FLEXITRUNK INFANT INTERFACE NASAL MASK