Catalog Number 0998-00-0800-53 |
Device Problems
Failure to Charge (1085); Device Maintenance Issue (1379); Retraction Problem (1536); Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/26/2017 |
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 per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The service territory manager (stm) replaced the li-ion battery pack and tether assembly.The stm then completed preventive maintenance and calibrated the iabp.The iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.The full name of the initial reporter is (b)(6).It was shortened to (b)(6) as per the character limit.The initial reporter is a company service territory manager.His contact information is as follows: (b)(6).
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Event Description
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A company service territory manager (stm) reported that while performing routine preventive maintenance (pm) he found the cardiosave plugged in but the battery in slot 1 was not accepting a charge and not functional on portable operation.The stm noted that battery 2 was ok.The stm also noted that the doppler tether was not retracting.No patient involvement or adverse event reported.
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Search Alerts/Recalls
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