RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Temperature Problem (3022); Excessive Heating (4030)
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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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Date of event: (b)(6) 2019.Date of report: 16july2019.A follow up report will be submitted once the evaluation is complete.
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Event Description
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The customer reported that the blower temperature was too high.There was no patient involvement.
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Manufacturer Narrative
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Date rec¿d by mfr: 27sep2019.Date of report: 30sep2019.The manufacturer¿s international service technician evaluated the ventilator and confirmed the reported problem.The service technician also identified that the pcba (printed circuit board assembly) bracket was broken and the battery failed testing due to deterioration.The service technician replaced the blower assembly, the pcba bracket and the battery.The ventilator successfully passed performance specification testing after the repair was completed.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: 15oct2019; b4: 16oct2019.The replaced blower was returned and failure investigation was performed on (b)(6) 2019.It was determined that a faulty temperature sensor within the blower caused the reported "blower temperature too high" error.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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