MAUDE Adverse Event Report: RESPIRONICS INC. PERFORMAX TOTAL FACE MASK; VENTILATOR, NON-CONTINUOUS RESPIRATOR

Model Number 1061619

Device Problem Use of Device Problem (1670)

Patient Problem Skin Erosion (2075)

Event Date 04/01/2014

Event Type  Injury  

Event Description

A mother of a (b)(6) alleges skin breakdown on the scalp due to the use of a small performax total face mask and headgear.The child was using the mask for the first 6 days of a 20 day hospital admission.This issue was reported over 1 week post discharge.To date there has been no medical intervention required.The mask was discarded by the facility and is not available for evaluation by the manufacturer.

Manufacturer Narrative

The performax total face mask meets all relevant iso standards for biocompatibility.The labeling included with this mask states: "the small size mask is to be used on patients 7 years or older (greater than 20kg) for whom cpap or bi-level therapy has been prescribed.Some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional." labeling also cautions the user "do not over tighten the headgear." based on the information available, the manufacturer concludes the reported event was most likely due to off-label use on a patient that is not intended for this type of mask, and that no further action is necessary.

• Brand Name: PERFORMAX TOTAL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS INC.; murrysville PA
• Manufacturer Contact: roger hyde ; 1740 golden mile highway; monroeville, PA 15146 ; 7243875690
• MDR Report Key: 3804565
• MDR Text Key: 4478432
• Report Number: 2518422-2014-00709
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2014

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: 1061619
• Device Catalogue Number: 1061619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/29/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 13