MalfunctionGWL
NIHON KOHDEN TELEMETRY PACK BATTERY
Received Jun 12, 2018 · Event occurred Jun 7, 2018
Report MW5077817 · MDR key 7596256
Device
Product problems
- Overheating of Device
- Peeled/Delaminated
Patient
70 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2018 AT 23:00, THE TELEMETRY PACK BECAME HOT, WHEN THE NURSE REMOVED TO INVESTIGATE, ONE OF THE BATTERIES (PROCELL AA 1.5V LR6 PC1500) HAD BEGAN TO PEEL. THE TELEMETRY PACK WAS REMOVED AND TAKEN OUT OF SERVICE. DATES OF USE: (B)(6) 2018, DIAGNOSIS OR REASON FOR USE: ELEVATED TROPONIN. "IS THE PRODUCT COMPOUNDED: NO, IS THE PRODUCT OVER-THE-COUNTER: NO."