Model Number 980 |
Device Problems
Defective Alarm (1014); Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The service engineer (se) inspected the device and installed a breath delivery (bd) power control pcba (printed circuit board assembly).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that, during preventative maintenance, a 980 ventilator was unable to pass the breath delivery (bd) audio test and alarmed with an error code.The ventilator was not in use on a patient at the time of the reported event.
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Manufacturer Narrative
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Device evaluation summary: the breath delivery (bd) power distribution printed circuit assembly (pca) was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: no fault found.There was no malfunction or product deficiency identified.The breath delivery (bd) power controller pca was returned for failure investigation.The part was visually inspected with no anomalies observed.The bd power controller pca was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.The ventilator passed power on self test (post) and no errors were recorded in the diagnostic logs.Ran calibration procedures without any errors.During extended self test (est), the ventilator failed the ¿bd audio test¿.The alarm audible tone was low and the "bd audio test" failed for "power fail cap not discharging".The fault was isolated to the capacitor, reference designator c4.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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