Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK SCREEN AND MACHINE OVERHEATING. PIL CONFIRMED THE DEVICE POWERED ON BUT DID NOT PROVIDE THERAPY. PIL WAS ABLE TO GET CARE ORCHESTRATOR DATA AND THE ERROR LOG BEFORE THE UNIT STOPPED WORKING AND THE SCREEN WENT BLACK. REVIEW OF THE ERROR LOGS SHOWED THE DEVICE HAS 1587.5 BLOWER HOURS AND 1587.4 THERAPY HOURS. THERE WERE TWO ERRORS LOGGED, ONE INSTANCE OF ERROR 53 (ERR_COMP_LOG_SEM_ TIMEOUT), A CONTINUE ERROR, AND ONE INSTANCE IF ERROR 130 (ERR_TASK_WDOG_TIME OUT), A REBOOT ERROR. CARE ORCHESTRATOR DATA WAS NOT AVAILABLE FOR DOWNLOAD DUE TO THE PCA NOT FUNCTIONING PROPERLY. A HEAT TEST WAS PERFORMED ON THE DEVICE, HEATER PLATE, AND PATIENT PORT TO VERIFY THAT THE TEMPERATURES WERE WITHIN THE REQUIRED PERIMETERS REQUIRED PER PRD 2300159 (V26). PIL TECH PERFORMED THIS TEST USING A PHILIPS RESPIRONICS TEST LUNG (PART #: 1021671, CALDUE: N/A), EXTECH IR THERMOMETER (ID: Z0190, CALDUE: 25JUN2025), AND OMEGA THERMOMETER (ID: F4314, CALDUE: 19OCT2024). THE TEST RESULTS SHOWED THAT THE DEVICE, HEATER PLATE, AND THE PATIENT PORT ALL SHOWED TEMPERATURES WITHIN THE THRESHOLD REQUIRED. RESULTS ATTACHED. PIL USED A KNOWN-GOOD PCA (PRINTED CIRCUIT ASSEMBLY) TO VERIFY THE DEVICE FUNCTIONED CORRECTLY AFTER BEING REPLACED. AFTER THE PCA WAS REPLACED, THE DEVICE POWERED ON AND THE DISPLAY CAME ON. THE PCA FROM THE RETURNED UNIT HAD A DEFECTIVE U15 (VOLTAGE REGULATOR), READING 0 VDC (VOLTS DIRECT CURRENT) INSTEAD OF 9 VDC. PIL VERIFIED PINS 2 AND 3 OF THE U15 WERE SHORTED. THE DEFECT IN THE U15 CAUSED IT TO BECOME VERY HOT. DURING THE INVESTIGATION, PIL OBSERVED FIBER-LIKE MATERIAL ON THE FRONT PANEL AND TOP ENCLOSURE. A DUST-LIKE CONTAMINANT WAS OBSERVED ON THE BLOWER. EVIDENCE OF LIQUID INGRESS WITH POTENTIAL MINERAL DEPOSITS WAS OBSERVED ON THE BLOWER AND BLOWER BOX. THERE IS NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. PIL WAS UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS. PIL CAN CONFIRM THE U15 ON THE PCA GOT TOO HOT AND THE SCREEN WAS BLACK. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.