This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for 00515047501, could not be performed as a lot number was not provided for the reported event.On (b)(6) 2019, it was reported from (b)(6) hospital that battery pack had ruptured after they had cut the battery pack cable.On 29 march 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device battery pack had ruptured and the battery pack cable was cut.The results of the returned product investigation have confirmed the reported event.The returned product investigation confirmed that the fan spray kit battery had ruptured due to a cut battery pack cable.The zimmer biomet pulsavac plus would debridement system instruction for use (ifu) states on page one to not cut the battery pack cable.An ifu is shipped to the customer with each purchased pulsavac system.Therefore, based on the information provided, the root cause of the battery pack rupturing was due to a cut battery pack cable.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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