RESPIRONICS, INC. HCPCS A7034 REF 1009041

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-21 for RESPIRONICS, INC. HCPCS A7034 REF 1009041 manufactured by Respironics, Inc..

Event Text Entries

[1683681] Increasing reaction to the toxic fumes that chinese made comfortgel nasal mask by respironics inc discharges to the point that i suffocate from complete airway blockage during sleep. This mask was provided to me by (b)(6). I have complained numerous times to (b)(6) sleep lab techs, dr. (b)(6), at no avail. Dose or amount: sleep apnea treatment, frequency: every day. Dates of use: comfortgel nasal mask for cpap since 2008. Diagnosis or reason for use: obstructive sleep apnea.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5018690
• MDR Report Key: 1938534
• Date Received: 2010-12-21
• Date of Report: 2010-12-20
• Date of Event: 2008-01-01
• Date Added to Maude: 2011-01-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: RESPIRONICS, INC.
• Generic Name: COMFORTGEL MASK W/HGR, DOM SIZE SMALL
• Product Code: BYP
• Date Received: 2010-12-21
• Model Number: HCPCS A7034
• Catalog Number: REF 1009041
• Lot Number: 101102
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1001 MURRY RIDGE LN. MURRYSVILLE PA 15668 US 15668

Device Sequence Number: 2

• Brand Name: RESPIRONICS, INC.
• Generic Name: COMFORTGEL MASK W/HGR, DOM SIZE SMALL
• Product Code: BYP
• Date Received: 2010-12-21
• Model Number: A7035
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: 1001 MURRY RIDGE LN. MURRYSVILLE PA 15668 US 15668

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2010-12-21