RESPIRONICS, REMSTAR PLUS 1005960

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-21 for RESPIRONICS, REMSTAR PLUS 1005960 manufactured by Respironics Inc..

Event Text Entries

[1018556] Began using a cpap machine from resmed in summer of 2005. In late spring of 2006, i noticed a shifting of 3 teeth no. 9, 10, 11. After many x-rays, ct scan, etc. It was determined that i had a cyst and significant bone loss in that area. A 25 cm cyst was removed in 2006. I then has a root canal of tooth #10 and was told that we would monitor the area for, hopefully, bone growth. About a year later i, again, noticed teeth movement. After all the tests, another cyst smaller, about 6-7 cm was removed in 2007. And i had a root canal on tooth #9. And, again was told that we would continue to monitor for bone growth. I noticed shifting again late this spring. At this time, i mentioned to my dentist and oral surgeon the problems that a friend had and we began speculating about whether the pressure of the cpap mask was a contributing factor to my problems. The consensus seemed to be yes. I stopped using the cpap machine and just got a new night-guard/positioning device. I will be seeing the oral surgeon yearly to monitor the situation and see if there is another cyst or if there is bone growth. That is my story in a nutshell. Dates of use: 2005--2008. Diagnosis or reason for use: sleep apnea.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5009706
• MDR Report Key: 1293983
• Date Received: 2009-01-21
• Date of Report: 2009-01-21
• Date of Event: 2006-05-01
• Date Added to Maude: 2009-02-04
• 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 Details

• Brand Name: RESPIRONICS, REMSTAR PLUS
• Generic Name: CPAP MACHINE
• Product Code: NHJ
• Date Received: 2009-01-21
• Model Number: 1005960
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668855 US 15668 8550

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-01-21