* CPAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-02 for * CPAP manufactured by *.

Event Text Entries

[607433] I was scheduled for a sleep study. After my electrodes had been attached, the technician arrived to explain how the tubing would be connected to my mask. I asked him if he could show me the bacteria filter which would be placed in-line between the cpap machine and the tubing to my mask. The technician said he did not have one and went to speak with his supervisor and supply. He returned ten minutes later and said neither his supervisor or supply had any bacteria filters. This was in spite of the fact that their cpaps were used by hundreds of pts. Most important was the sticker on the front of the cpap machine that warned "if this machine is used on multiple pts a bacteria filter must be used. " i left the clinic for forty minutes to travel to my home to retrieve a bacteria filter from my home. I had the filters because i sometimes have to rent cpap machines. Representatives of respironics have advised me to use bacteria filters when i use any machine which has been used by another person. The sleep disorders clinic and dr were unaware of the need to use bacteria filters. It would be advisable that the clinic be required to provide notice to their pts about their possible exposure to bacteria.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1042444
• MDR Report Key: 835285
• Date Received: 2007-04-02
• Date of Report: 2007-04-02
• Date of Event: 2007-03-11
• Date Added to Maude: 2007-04-10
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: CPAP
• Product Code: NHJ
• Date Received: 2007-04-02
• Model Number: CPAP
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 822613
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-04-02