Model Number 801763 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported that the batteries on the heart lung machine (hlm) would not charge.No other details regarding the nature of the event were provided.
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Manufacturer Narrative
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The field service representative (fsr) verified the heart lung machine (hlm) displayed a two year battery service message.He replaced the batteries.The unit operated to the manufacturer's specifications.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician observed the batteries to be received at 13.08 volts direct current (vdc) and 487 siemens (s) for the first battery and 13.08 vdc and 486 s for the second battery, both passing.The batteries were fully charged and then attached to a load simulator.The batteries lasted for 76 minutes, 52 minutes is passing.
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Manufacturer Narrative
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The reported complaint could not be confirmed.Per data log analysis, the complaint was called in on (b)(6) 2019, the date the problem occurred (battery not charging) was not provided.The logs were exported on (b)(6) 2019.The system log goes back to (b)(6) 2019 and did not even cover the date the complaint was called in.The power manager log covers a much longer time frame.According to the power manager log, the system was powered up on (b)(6) 2019.The system was left powered on until the log was exported on (b)(6) 2019.During that time the system was on battery backup a total of five times without losing power (battery backup was functional).There was no way to tell what the battery capacity was during that time from the power manager log.The system log showed the battery capacity was full (15/16) from (b)(6) 2019 to (b)(6) 2019.It was possible the power manager detected the battery capacity was low when battery backup was tested during the long power up time.This may cause the light emitting diode (led) to be red, but since the system log does not cover that time period there is no way to tell from the log.There is also no way to tell if battery charging is functional since battery backup was never tested in the system log.The system did not detect a problem with the battery charging circuit.The complaint cannot be confirmed from the log.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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