RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Loss of Power (1475); Battery Problem (2885)
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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) 2020.Date of report: 31jul2020.
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Event Description
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It was reported that while in use, the ventilator did not sound a "low internal battery" alarm, and the power turned off.Reportedly, the unit was used without the external power connected.The customer reported that the power turned off due to the battery depleting.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.Patient information was not disclosed.The manufacturer's international service technician confirmed the reported issue.The battery will be replaced.
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Manufacturer Narrative
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G4: 29sep2020.B4: 30sep2020.The manufacturer¿s international service technician inspected the device and found that the unit had an "low internal battery" then the unit shutdown.The service technician replaced the battery to address the reported issue and in addition found the power on/ off light emitting diode (led) would not illuminate.The service technician replaced the power switch overlay to address the issue.The unit was checked overall, run in tested, cleaned, 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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G4: 02nov2020; b4: 03nov2020.A power switch panel was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.An investigation was performed and the product analysis technician reported that the root cause was power on (green) & alternating current (amber) light emitting diode (led) trace was found broken that created the led not to illuminate.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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