DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that during preventive maintenance (pm) that the cs300 intra-aortic balloon pump (iabp) displayed an electrical error #52.Customer brought machine to field service engineer fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Testing of actual/suspected device (10,3213) a getinge field service engineer (fse) evaluated the iabp during a routine pm.Customer brought machine to fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.Fse found the machine quenched in saline, the front board was damaged.Fse replaced the front end pcb, (0670-00-0668), which corrected the issue.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted if this information is provided to us.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).
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Event Description
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It was reported that during preventive maintenance (pm) that the cs300 intra-aortic balloon pump (iabp) displayed an electrical error #52.Customer brought machine to field service engineer fse, who turned it on, and then machine went into a system alarm and displayed an electrical error 52.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period oct 2019 through sep 2021 was reviewed.There were no triggers identified for the review period.
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Event Description
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N/a.
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Search Alerts/Recalls
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