Description of Event or Problem · 0
1) ON (B)(6), 2023, DALTON MEDICAL HAS DONE AN ONSITE INSPECTION AT MEMORIAL HERNAMM HEALTH IN (B)(6), TX. THE INSPECTION INCLUDED THE TRANSFORMER AND INNER MATERIALS. WE TAKEN PHOTOS AND THERE IS NOTHING FOUND WITH THE MACHINE (SEE FILE ATTACHMENT: EVIDENCE 1 OF 1). 2) ON (B)(6), 2023, WE HAVE BEEN NOTIFIED BY THE CUSTOMER: MAX FROM MEMORIAL HERMANN HEALTH SYSTEM OF (B)(6), TEXAS. PER MAX, THEY HAD REPORTED TO FDA REGARDING AN OXYGEN CONCENTRATOR THAT WE SOLD TO THEM CAUGH ON FIRE AT PATIENT SITE THAT DAMAGED THE CARPET (SEE FILE ATTACHMENT: MDR REPORT MW5144602BY THE INITIAL REPORTER). 3) WE ASKED THEM TO PROVIDE US WITH MORE INFORMATION ABOUT THIS INCIDENT. WE WILL ISSUE A UPS CALL-TAG TO GET THE CONCENTRATOR BACK FOR IMMEDIATELY INVESTION BY THE DEVICE MANUFACTURER. 4) MEMORIAL HERMANN HEALTH SYSTEM EMAILED US WITH THE PHOTOS OF OXYGEN CONCENTRATOR RELATING THE INCIDENT. 5 DALTON MEDICAL EMAILED THE PHOTOS TO THE DEVICE MANUFACTURER FOR ANALYSIS. 6) THE DEIVICE MANUFACTURER CONCLUDED THAT THE FIRE COMBUSTION AT THE TIME WAS ON THE OUTER SURFACE OF THE OXYGEN CONCENTRATOR MACHINE BUT NOT THE INTERNAL COMBUSTION OF THE MACHINE. THE DEVICE MANUFACTURER'S REPORT ALSO ASSESSED THE FIRE COMBUSTION WAS CAUSED BY THE LINEAR OBJECTS ON THE CARPET OR PERSON SMOKED AROUND THE OXYGEN CONCENTRATOR MACHINE (SEE FILE ATTACHMENT: ANALYSIS FOR THE FIRE INCIDENT REPORT).