Model Number 801764 |
Device Problem
Failure to Run on Battery (1466)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/10/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Per the manufacturer's subsidiary, the battery icon color on the central control monitor (ccm) and the light emitting diode (led) on the front panel of the hlm were both green.
|
|
Event Description
|
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the heart lung machine (hlm) would not switch from alternating current (ac) to battery power.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
|
|
Manufacturer Narrative
|
Evaluation is in progress, but not yet concluded.
|
|
Manufacturer Narrative
|
Per the manufacturer's subsidiary, the power manager board was defective.
|
|
Manufacturer Narrative
|
Updated blocks: h3 and h6 the reported complaint was confirmed.During laboratory analysis, the product surveillance technician observed the power manager could not switch from alternating current to battery.Microscopic examination of the power manager boards found that there were several charred resistors.The resistance across r186, r159 and r122 resistors showed that the circuits were open.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Search Alerts/Recalls
|