ENVISION BLOWER KIT

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI)#: THE MANUFACTURING DATE (11) IS NOT KNOWN AT THIS TIME, THEREFORE THE UDI NUMBER ONLY CONTAIN SERIAL NUMBER (B)(6). H11: THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL, EXAMINE THE POWER CORD AND ITS PLUG FOR DAMAGE. EXAMINE THE LENGTH OF THE POWER CORD FOR CUTS AND ABRASIONS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND ATTACH THE ANALYZER TO THE EXPOSED METAL CHASSIS GROUND TEST POINT TO MAKE SURE THE GROUND RESISTANCE IS NO MORE THAN 200 MILLIOHMS. PLUG THE POWER CORD INTO A CALIBRATED SAFETY ANALYZER AND MAKE SURE THE LEAKAGE CURRENT IS NO MORE THAN 300 MICROAMPS IN NORMAL CONDITION (NC). REPLACE AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JAN 15, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT ENVISION BLOWER KIT (PRODUCT CODE P136026, SERIAL NUMBER (B)(6)), HAD THE POWER CORD DAMAGE WITH EXPOSED COPPER WIRES. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.