The following was reported to us.In at least three cases the battery of a transporter malfunctioned.Because the battery did not work, the transporters could not be moved to trendlenburg position.Due to this malfunction mayor complications occurred in at least three cases.Further information concerning the nature of these incidents was requested from the clinic, but not yet received.Manufacturer reference# (b)(4).
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According to a statement from the clinic, the batteries were charged.The green led which indicates the charging state was on.After the incidents occurred it was tried to charge the batteries again.This was not possible.On the (b)(6) 2020, the batteries were swapped.After this swap, no more problems occurred.That is why we assume that the malfunction is limited to the batteries and not related to other products or a special kind of use.The batteries were returned to the manufacturing site.Since a deep discharge occurred, a root cause investigation was not possible.We have requested the records of final inspection from the supplier.The investigation of this records resulted in no indications.If this malfunction reoccurs in the future, we will if possible, pick up the batteries immediately.This way an investigation can be performed before the batteries are in the deep discharge state.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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The following information was received concerning the nature of the incidents.Via a user report we were informed that batteries which are used in a transporter have failed.The transporter is used to transport patients and can be adjusted.Since the batteries failed the transporters could not be adjusted.One patient was prepared for surgery.He complained about nausea.Next it was tried to move the transporter to the shock position (head down).This was not possible.The patients legs were lifted.Neither the treatment of the patient nor the hospital stay were prolonged.No subsequent damage occurred.The clinic reported complications in three cases.The event dates for these cases were "mid to end of (b)(6) 2020".The range could not be narrowed down further.According to a statement from the clinic, only fully charged batteries were used.The led, which indicates the charging state of the batteries, was green.This indicates the battery is fully charged.Afterwards it was not possible to determine the serial numbers of the batteries which were used when the three incidents occurred.The serial numbers could be narrowed down to the following range: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6), (b)(6) and (b)(6).Manufacturer reference # (b)(4).
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