MASTERSCREEN BODY
Received Jan 3, 2017 · Event occurred Dec 5, 2016
Report 2021710-2017-05167 · MDR key 6220679
Device
Generic name
Plethysmograph, Volume
Manufacturer
Carefusion, IncModel number
MS-BODY/DIFF SESCatalog number
30336-001
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR DETERMINED THAT THE DEVICE HAD A DEFECTIVE DEMAND VALVE AND THE COMPONENT WAS REPLACED. AFTER THE REPAIR, THE DEMAND VALVE WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. AT THIS TIME, THE CUSTOMER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED WHILE PERFORMING A LUNG DIFFUSION CARBON MONOXIDE (DLCO) TEST THE DEMAND VALVE IS CONTINUOUSLY BLOWING DURING THE PATIENT'S EFFORTS AND THE PATIENT COMPLAINED, "IT HURT HER LUNGS". THERE WAS NO FURTHER INFORMATION REGARDING PATIENT HARM OR INJURY WITH THE REPORTED ISSUE, IT IS CURRENTLY UNKNOWN.