Model Number 801763 |
Device Problems
Battery Problem (2885); Output Problem (3005)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Per the field service representative (fsr) the user facility's biomedical engineer stated that there were power issues in the operating room.
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Event Description
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It was reported that the heart lung machine (hlm) had a battery error issue.No other details regarding the nature of the event were provided.
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Manufacturer Narrative
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The reported complaint was confirmed.The product surveillance technician duplicated the reported complaint.He observed the voltage to be too low that it was unable to power on the fans of the power supply's.The voltage was reading 0.112 volts direct current (vdc), specification is 24.5 vdc +/- 5%.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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Event Description
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Additional information received that the surgical procedure was completed successfully.No adverse consequences to the patient.
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Manufacturer Narrative
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The field service representative (fsr) was unable to duplicate any issues.After consulting further with the user facility's biomedical technician it was determined that a bad power outlet caused the heart lung machine (hlm) to go onto battery power without the user knowing.There are no issues with the battery or the hlm.
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Search Alerts/Recalls
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