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Model Number V200 |
Device Problem
Device Emits Odor (1425)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2019.Date of report: 12/09/2019.
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Event Description
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The customer reported that the ventilator was emitting a burning odor.It is unknown if the ventilator was being used on a patient at the time of the reported event, however, there was no patient harm.
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Manufacturer Narrative
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G4: 06may2020, b4: 08may2020.The replaced blower motor controller (bmc) was returned for failure analysis.Visual inspection revealed heat related damage on a pin connector, which was determined to be a cosmetic issue with no odors produced.The bmc was tested and no functional failures were identified.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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G4: 17dec2019.B4: (b)(6).Although requested, the customer did not confirm if there was patient involvement at the time of the reported event.The fse (field service engineer) evaluated the ventilator and confirmed the reported problem.The fse replaced the blower motor controller printed circuit board assembly and the problem was resolved.The ventilator successfully passed performance specification testing after the repair was completed.The determination could not be made that the device failed to meet specifications.It is unknown if the device was being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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