MAUDE Adverse Event Report: RESPIRONICS, INC WISP MASK, FABRIC FRAME; VENTILATOR NON-CONTINUOUS RESPIRATOR

Model Number 1094051

Device Problem Use of Device Problem (1670)

Patient Problem Scarring (2061)

Event Date 02/23/2016

Event Type  Injury  

Event Description

An end user alleged that she developed scarring while using the wisp mask.The end user was treated with antibiotics and a topical ointment.The mask has been discarded and is not available for evaluation.The alleged scarring was reportedly caused by a pressure sore, which is most likely a result of overtightening.The end user noted redness a week after first being given the mask, but continued to use it for 2-3 weeks after the initial allergic reaction.The wisp mask meets all relevant iso standards for biocompatibility.Instructions for use for this mask states: "some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional." "do not overtighten the headgear straps.Watch for signs of overtightening, such as excessive redness, sores, or bulging skin around the edges of the mask.Loosen the headgear straps to alleviate symptoms." based on the information available, the manufacturer concludes the reported event was most likely caused by the end users failure to follow instructions for use, and that no further action is necessary.

• Brand Name: WISP MASK, FABRIC FRAME
• Type of Device: VENTILATOR NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington 15068 ; 7243349303
• MDR Report Key: 5492153
• MDR Text Key: 40057387
• Report Number: 2518422-2016-00852
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K121631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2016

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: Lay User/Patient
• Device Model Number: 1094051
• Device Catalogue Number: 1094051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 46 YR