Model Number 0998-00-0800-83 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.Customer had an accessory removable power supply that was no longer charging.Fse replaced power supply which resolved charging issue.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during a routine check on the cardiosave intra-aortic balloon pump (iabp) one of the batteries was faulty and wouldn't charge.It flashed red in either compartment.There was no patient involvement thus no adverse event reported.
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Event Description
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N/a.
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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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Search Alerts/Recalls
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