FDA Adverse Event Other Summary report: N

SALTER LABS

MDR report key: 666302 · Received December 3, 2005

Report

Report Number
MW1037342
Event Type
Other
Date Received
December 3, 2005
Date of Event
June 1, 2003
Report Date
December 3, 2005
Manufacturer
SALTER LABS
Product Code
CAT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

REPORTING PVC USED FOR HEALTH PRODUCTS, ESPECIALLY FOR TUBING AND CANNULAS WITH OXYGEN MACHINES. RPTR WISHES TO REPORT A PRODUCT THAT THEY FEEL DOES EXTENSIVE DAMAGE TO LARGE NUMBERS OF PEOPLE. RPTR'S OPINION IS BASED ON PERSONAL EXPERIENCE AND SUPPORTED BY RESEARCH THEY HAVE READ. HERE IS RPTR'S PERSONAL EXPERIENCE. RPTR HAS BEEN DIAGNOSED WITH SLEEP APNEA. RPTR WAS UNABLE TO FIND A C-PAP MACHINE THEY COULD USE BECAUSE THEY SURPRISINGLY HAD CLAUSTROPHOBIC REACTIONS, SO PULMUNARY DOCTOR PRESCRIBED THAT THEY USE AN OXYGEN MACHINE AT NIGHT. ATTACHED TO THE OXYGEN MACHINE WAS THE USUAL PVC TUBING AND CANNULA. THE FIRST DAY AFTER RPTR USED IT THEY FELT ENERGIZED. THEY CAME TO THE CONCLUSION THAT THEY DEFINITELY NEEDED OXYGEN AT NIGHT. HOWEVER, AFTER USING THE OXYGEN WITH THE PVC CANNULA AND TUBING FOR THE SECOND NIGHT, AND CONTINUOUSLY AND ON INTO THE NEXT WEEK RPTR DEVELOPED MORE DIFFICULTY BREATHING. AND, EVEN MORE DRAMATIC WERE THE REACTIONS TO THEIR BRAIN. RPTR BECAME ANGRY AND SAD. RPTR CRIED ALMOST UNCONTROLLABLY OFF AND ON WITHOUT UNDERSTANDING WHAT WAS MAKING THEM SAD. RPTR BECAME VERY ANGRY OVER THINGS THAT WOULD NORMALLY NOT BOTHER THEM AT ALL. RPTR CAME TO THE CONCLUSION OVER TIME THAT THEIR INCREASED BREATHING DIFFICULTIES DURING THE DAY AFTER USING OXYGEN AND THE STRANGE AND UNUSUAL EMOTIONAL REACTIONS THAT DEVELOPED ALSO AFTER USING OXYGEN THE NIGHT BEFORE WERE CAUSED BY FUMES FROM THE SOFT PVC CANNULA AND TUBING. WHEN RPTR STOPPED UISNG THE PVC CANNULA AND TUBING AND STOPPED BREATHING THE FUMES THE UNUSUAL BEHAVIOR TOTALLY STOPPED AND BREATHING WENT BACK TO THE WAY IT HAD PREVIOUSLY BEEN. RTPR TRIED USING THE CANNULA, TUBING AND OXYGEN AGAIN AND AGAIN OVER TIME, AND EACH TIME THEY DID IT SEEMED THAT BREATHING BECAME MORE LABORED AND BEHAVIOR BECAUSE UNUSUAL AND INCLUDED THE ANGRY AND CRYING SPELLS; TO THE POINT WHERE RPTR DIDN'T WANT TO BE AROUND PEOPLE FOR FEAR OF LOSING FREINDS AND OFFENDING PEOPLE THAT RPTR LIKED OR DIDN'T EVEN KNOW. IT HAS TAKEN RPTR OVER TWO YEARS, BUT RPTR FINALLY FOUND A SUBSTITUE FOR THE PVC TUBING. RPTR FOUND MEDICAL GRADE STAINLESS STEEL TUBING, BUT THEY HAVE BEEN UNABLE TO FIND A CANNULA. RPTR HAS BEEN USING THE OXYGEN AT NIGHT WITH ONLY THE STAINLESS STEEL TUBING, AND PLACED THE TUBING BESIDE PILLOW. RPTR DOESN'T GET AS MUCH OXYGEN AS IF THEY HAD A CANNULA, BUT IT DEFINITELY HELPS. OVER TIME NEW C-PAP MACHINES HAVE BEEN MADE THAT USE ONLY CANNULAS INSTEAD OF THE PREVIOUS HEAVY MASKS. RPTR THINKS THEY COULD HANDLE THE C-PAP MACHINES THAT USE ONLY CANNULAS AS FAR AS CLAUSTROPHOBIA IS CONCERNED. HOWEVER, AS FAR AS THEY CAN TELL THOSE CANNULAS ARE ALL MADE WITH PVC SO THEY ARE NOT ABLE TO USE THEM EITHER. RPTR HOPES THAT THE FDA WILL ENCOURAGE MFRS TO COME UP WITH CANNULAS AND TUBINGS MADE OF MATERIAL OTHER THAN PVC. RPTR HAS STUDIED RESEACH ABOUT PVC. THERE HAS BEEN A LOT OF IT DONE AFTER 9/11/2001 WHEN IT WAS DISCOVERED THAT THE CLOUDS THAT CAME UP OVER THE DESTRUCTION OF THE WORLD TRADE CENTER CONSISTED MOSTLY OF PVC THAT WAS USED IN THE BLDGS. THAT RESEARCH SHOWS THAT PVC CAUSES LUNG CANCER IN ADULTS AND ASTHMA IN CHILDREN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SALTER LABS CANNULA AND TUBING FOR OXYGEN MACHINE CAT SALTER LABS 1615 111703

Patients

Seq Age Sex Outcome Treatment
1 61 YR Other