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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is provided.(b)(6).
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Event Description
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It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) experienced a power supply failure.There was no patient involved; thus, no adverse event reported.
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Event Description
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It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cs300 intra-aortic balloon pump (iabp) experienced a power supply failure.The iabp unit would not turn on without batteries; and when the batteries were connected the unit would turn on and show ¿low battery¿, indicating that the unit was not charging.There was no patient involved; thus, no adverse event was reported.
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Manufacturer Narrative
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The getinge fse evaluated the iabp unit and narrowed the issue down to the power supply.The fse checked the function of the fuses, solenoid driver board, power cord, and power supply ac toggle switch.The fse identified zero volts with digital multi-meter going into battery pack from the power supply.The fse noted the rate of the battery charging and concluded that iabp needed a new power supply.Due to military funding requirements for transactions over (b)(6), the customer asked for the new power supply to be installed at a later date until funding for the estimated repair amount was processed through their system.The fse ceased the preventative maintenance (pm) until the power supply was replaced.The fse later received the purchase order and coordinated the repair of the unit.The fse installed the new power supply and replaced the batteries, as requested.Pm was completed, and the iabp unit was calibrated and passed all functional and safety tests per factory specifications.The unit was returned to the customer and cleared for clinical use.
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Search Alerts/Recalls
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