RUSCH TRULED ADULT RECHARGEABLE BATTERY
Received Aug 22, 2016 · Event occurred Aug 5, 2016
Report 3011137372-2016-00243 · MDR key 5893415
Device
Product problems
- Battery Problem
- Battery Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED REVIEWED ON THE LOT NUMBER OF THE SAMPLE RECEIVED (1451V3) AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE SAMPLE WAS RETURNED FOR EVALUATION. THE LED WOULD NOT ENERGIZE UPON RECEIPT. THE CARTRIDGE WAS CONNECTED TO A KNOWN GOOD CHARGING UNIT (LOCATED ON THE CHARGING END OF THE DEVICE). IMMEDIATELY THE CARTRIDGE WENT INTO A BATTERY/CIRCUITRY FAIL MODE WITH THE RED CHARGING LIGHT FLASHING. THE UNIT WAS COMPLETELY DISASSEMBLED FOR FURTHER INVESTIGATION. THERE WERE NO VISUAL SIGNS OF CORROSION ON EITHER END OF THE BATTERY, TO INCLUDE THE BATTERY ITSELF, SOLDERED JOINTS, AND PCBS. WIRES WERE FIRMLY ATTACHED. AFTER DISCONNECTING PCB FROM BOTH ENDS OF THE BATTERY A VOLTAGE TEST REVEALED THAT THE LI-ION BATTERY WAS ALMOST FULLY CHARGED AT 3.6 VDC. A CONCLUSION CODE COULD NOT BE CHOSEN AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE BATTERY IS EITHER BROKEN OR HAS FAILED. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4). PRODUCT USAGE WHEN THE ALLEGED ISSUE WAS DETECTED IS UNKNOWN. THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT THE BATTERY IS EITHER BROKEN OR HAS FAILED. NO PATIENT INJURY REPORTED.