Model Number 0998-00-0800-53 |
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 04/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was assigned to investigate the reported issue.The stm called the customer and asked the customer's biomed to plug the device.The biomed plugged the device back in, reseated the batteries and the batteries charged up accordingly.The biomed returned the unit for clinical service.The getinge fse reported that batteries were able to charged to full capacity and the issue was solved over the phone.Service was completed by phone call.
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Event Description
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It was reported that the battery in the cardiosave intra-aortic balloon pump (iabp) will not charge "unusable battery in bay1".There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/213) the device history records 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: (4109/213) 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: (4110/213) the overall 24 month product complaint trend data for the period (may-2019 through apr-2021) was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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