MAUDE MDR 835285

MDR report key
835285
Report number
MW1042444
Event key
0
Event type
3
Date of event
2007-03-11
Date received
2007-04-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*CPAP*NHJCPAP**YY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-04-0201. O

Event Narratives#

D

Patient 1

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.