| Product Name/Description |
Li-Ion Rechargeable Battery for corpuls CPR
Battery Serial Numbers: A240400034, A240400035, A240400036, A240400041, A240400042, A240400043, A240400044, A240400045, A240400046, A240400048, A240400049, A240400050, A240400051, A240400052, A240400053, A240400054, A240400055, A240400056, A240400063, A240400064, A240400095, A240400096, A240400135
All products using battery batch A1075843 |
| Reason for the Action |
GS corpuls has been advised by their third-party battery manufacturer of a problem with a specific batch of Lithium-Ion batteries used in the corpuls CPR.
Further investigation found that some batteries may be affected and may have a higher risk of unexpected failure. According to the manufacturer, approximately 3% of the batteries used, from the affected batch, may develop an electrical defect due to poorly soldered joints, which could cause sudden battery failure.
An unexpected battery failure can cause the mechanical CPR device to be temporarily unavailable during use. This may result in interruptions or delays in life-saving treatment during emergency situations and, in worst case, lead to serious health consequences for patients.
There have been no reports of serious incidents resulting in patient harm related to this problem. |