Model Number 550AHCT |
Device Problems
Thermal Decomposition of Device (1071); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2021 |
Event Type
malfunction
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) would not turn on.As a result, an alternate device was employed.No further details regarding the nature of this event were provided.During laboratory evaluation of the unit, it was found that an internal capacitor had failed and showed signs of damage from overheating.
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Manufacturer Narrative
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Per the user facility's biomedical technician, the unit only had a green light lit on the back and did not have an audible tone when booting up like normal, only a black screen.During laboratory evaluation of the device, the product surveillance technician (pst) observed the monitor to not power on, but the charge indicator light was on, which meant the power supply was functioning properly.He disassembled the unit and found a damaged capacitor at the c137 position on the auxiliary (aux) printed circuit board (pcb).There was a short circuit condition between the 12 volt (v) switch and ground across the capacitor causing it to fail.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.
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Manufacturer Narrative
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The reported complaint was confirmed.Per supplier evaluation, the printed circuit board assembly (pcba) was visually inspected upon receipt where it was determined there was a burned capacitor at location c137 and a missing transistor at location q10.The board was not tested as it was expected to fail due to the visual defects found.The pads at location q10 showed evidence in the solder left that there the transistor was placed and soldered there.Based on device history records, the board was fully functional upon initial shipment to the manufacturer.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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Manufacturer Narrative
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The service repair technician (srt) duplicated the reported complaint.The cause was a defective auxiliary (aux) printed circuit board assembly (pcba) board.The srt replaced the aux pcba board and the monitor powered up successfully.The unit operated to the manufacturer's specifications.
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Search Alerts/Recalls
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