This event has been recorded by zimmer biomet under (b)(4).This follow-up report is being submitted to relay additional information.Review of the device history record for 00515047501, lot number z000007888, identified no relevant deviations or anomalies.Product examination found that only the battery pack was returned for this complaint.The batteries inside the battery pack had ruptured due to a short circuit.This complaint is confirmed.However, the wire was cut by the customer.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ (b)(4) is in process to directly address customers cutting the battery cable.The root cause of the reported event is that the customer cut the wire.Cutting the wire has the risk of causing a short circuit of the battery pack.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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