MAUDE Adverse Event Report: CAREFUSION, INC UNKNOWN; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: multiple attempts have been made to gather additional information from the customer regarding the product code used, patient demographics, and what treatment was provided if any to the patient.To date no information has been made available from the customer.Cfn marketing has been contacted and has confirmed that the alleged product could be one of the following codes 777040xs, s, s/m, m, l, and xl.However, we are unable to confirm the actual product code without the customers response.Marketing has provided the customer with training resources regarding the proper use of the cpap headgear to eliminate straps one and three from being too tight.If any further information becomes available a supplemental submission will be filed.(b)(4).

Event Description

Customer reported the following "we have been having issues with the cpap headgear.Babies heads are becoming misshapen with overlapping cranial sutures".

• Brand Name: UNKNOWN
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6099062
• MDR Text Key: 59788607
• Report Number: 8030673-2016-00259
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention