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

Model Number 1094051

Device Problem Use of Device Problem (1670)

Patient Problems Dry Eye(s) (1814); Eye Injury (1845)

Event Date 05/26/2016

Event Type  Injury  

Event Description

An end user alleged that she was harmed when she developed eye irritation and dryness while using the wisp mask.The end user stated that she noticed air leaks at initiation of use, but continued to use different sizes of the mask over a period of 18 months.The end user was advised by a physician to discontinue use of the mask.The end user further alleges that she will require eye surgery as a result of the reported issues with the mask, but no medical intervention has been reported to date.The manufacturer has made numerous attempts to contact the end user for additional information and to request all mask(s) for investigation.At this time, no further information has been received, and no product has been returned.There was no lot number provided for masks reportedly used.Instructions for use for this mask provides directions for achieving the proper fit, and state, "some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional.Consult a physician if you experience the following symptoms while using the mask or after removing it: drying of the eyes, eye pain, eye infections, or blurred vision.Consult an ophthalmologist if symptoms persist." the user is further instructed "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 is unable to confirm the end user's allegation.No further action is necessary.If additional information is obtained, or if product is returned, the manufacturer will file a follow up report.

• Brand Name: WISP MASK, FABRIC FRAME, W/ HDGR
• 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: 5738045
• MDR Text Key: 47824193
• Report Number: 2518422-2016-02745
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/26/2016

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: 05/26/2016
• Initial Date FDA Received: 06/21/2016
• 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: 72 YR