Description of Event or Problem · 1
I PURCHASED A PULSE OXIMETER TO HELP MANAGE MY DAUGHTER'S R.A.D. ON AMAZON.COM -THIS PARTICULAR DEVICE IS ALSO SOLD ON SEVERAL OTHER SITES-. THE DEVICE IS MARKETED AS A "PEDIATRIC PULSE OXIMETER C-52 FDA APPROVED." THE DEVICE IS A CLIP ON FINGER PULSE OXIMETER "WITH A BEAR DESIGN." ACCORDING TO THE PRODUCT PACKAGING IT IS MANUFACTURED IN (B)(4). THE MARKETING CLAIMS, ON AMAZON AND OTHER SITES, ARE THAT THIS DEVICE IS FDA APPROVED FOR PEDIATRIC USE. SEE: HTTP://WWW.AMAZON.COM/C5-CHILDRENS-FINGERTIP-OXIMETER-DESIGN/DP/B0039O9SF2/REF=PD_SBS_HPC_1. ALSO: HTTP://WWW.PULSEOXIMETERSDIRECT.COM/PEDIATRIC-FINGER-OXIMETER-C-52-P/PED%20C-52.HTM, AND THE PRESS RELEASE AT: HTTP://WWW.24-7PRESSRELEASE.COM/PRESS-RELEASE/PULSE-OXIMETER-FOR-CHILDREN-C52-INTRODUCED-BY-PULSEOXIMETERSDIRECTCOM-141564.PHP. WHEN I RECEIVED THE DEVICE, I TRIED TO USE THE DEVICE BY PLACING IT ON EACH OF MY DAUGHTER'S FINGERS. WITH THE EXCEPTION OF HER MIDDLE FINGER, THE READINGS WERE ALL OVER THE BOARD- RANGING FROM 88% TO 98%. I WAS ABLE TO OBTAIN CONSISTENT READINGS FROM MY DAUGHTER'S MIDDLE FINGER, BUT AS I DO NOT HAVE ANOTHER OXIMETER, WAS NOT ABLE TO DETERMINE WHETHER THE READINGS WERE ACCURATE. THE SITES WHERE THIS DEVICE IS ADVERTISED INDICATE THAT IT IS SPECIFICALLY FOR PEDIATRIC USE, INCLUDING NEONATE USE. CLEARLY, THE DEVICE DOES NOT FUNCTION WITH ACCURACY ON SMALL FINGERS. THIS IS ALARMING, AS I WOULD BE UNABLE TO TELL IF THE DEVICE WAS GIVING AN INCORRECT READING OF MY DAUGHTER'S OXYGEN LEVELS. IN ADDITION, I WAS ALARMED TO FIND THAT THE INSTRUCTIONS THAT WERE INCLUDED WITH THE DEVICE WERE EXTREMELY POOR- THEY REFERRED TO FUNCTIONALITY THAT THE DEVICE DID NOT HAVE; FOR EXAMPLE "DO NOT STRETCH THE ADHESIVE TAPE WHILE APPLYING THE PULSE OXIMETER SENSOR. THIS MAY CAUSE INACCURATE READINGS OR SKIN BLISTERS." THERE IS NO ADHESIVE TAPE ON THIS PRODUCT, AND NO WAY TO ATTACH ANY ACCESSORY DEVICES, SO THIS INSTRUCTION CLEARLY DOES NOT APPLY TO THE PRODUCT. FURTHERMORE, I WORK FOR (B)(6) AND SHOWED THIS DEVICE AND ITS PACKAGING TO OUR REGULATORY AFFAIRS PERSONNEL. THEY NOTED THAT THE DEVICE IS NOT PROPERLY LABELED. AMONG OTHER PROBLEMS: THERE IS NO INFO ON WHERE THE DEVICE IS MANUFACTURED LISTED ON THE DEVICE LABEL -NEXT THE FACTORY SYMBOL IS A DATE OF, PERHAPS, MANUFACTURE?-. THERE IS NO LOCAL DISTRIBUTOR FOR THE DEVICE LISTED. FINALLY THE DEVICE IS LABELED AND ADVERTISED AS FDA APPROVED, BUT AFTER AN EXTENSIVE SEARCH ON THE FDA WEBSITE, WE COULD FIND NO RECORD THAT THIS DEVICE HAD ACTUALLY BEEN APPROVED BY THE FDA. BECAUSE OF THE PROBLEMS WITH REPEATABILITY IN MEASURING OXYGEN SATURATION LEVELS ON A PEDIATRIC PT, THE LABELING PROBLEMS, THE PACKAGING PROBLEMS AND WHAT APPEARS TO BE FALSE ADVERTISING AROUND FDA APPROVAL OF THE DEVICE, I AM REPORTING THIS AS A SERIOUS PRODUCT PROBLEM. I WOULD NOT FEEL COMFORTABLE RELYING ON THIS DEVICE TO MAKE MEDICAL DECISIONS ABOUT MY DAUGHTER'S HEALTH GIVEN THESE PROBLEMS. IN FACT, I AM CONCERNED THAT PEOPLE COULD FALSELY ASSUME THAT THE PT'S OXYGEN SATURATION WAS HIGHER THAN WAS ACTUALLY THE CASE. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: REACTIVE AIRWAY DISEASE.