RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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: 30april2019.A follow-up report will be submitted once the investigation has been complete.
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Event Description
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Customer contacted technical support (ts) stating that unit had blower overload.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Event date not specified, estimate used.
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Manufacturer Narrative
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Date rec¿d by mfr : 06aug19, date of report : 07aug19.The manufacturer¿s field service engineer (fse) confirmed the reported blower issue.The manufacturer¿s field service engineer (fse) replaced the blower to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed 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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Mfr received date: 28 aug 2019.The blower assembly passed all testing.A high blower temperature alarm could not be duplicated.There were no faults found with the blower assembly.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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