RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Break (1069); Display or Visual Feedback Problem (1184)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2018.Date of report: 31dec2018.(b)(4).No phone number provided.A follow-up report will be submitted once the investigation has been complete.
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Event Description
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The customer reported that the alarm silencing button is unable to press.Settings were not able to change, but calibration was performed then the setting are able to change, but alarm silencing button and alarm reset button do not work.There was no patient involvement.The event date was not specified; estimate used.
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Manufacturer Narrative
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Pma/510k: 02oct2019.Date of report: 02oct2019.The part was returned to the manufacturer for failure investigation (fi).It was determined that the ul_lr and ur_ll resistance and resistance ratio were out of specification.Fault was found on this returned touchscreen.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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Event Description
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The customer reported that the alarm silencing button is unable to press.Settings were not able to change, but calibration was performed then the setting are able to change, but alarm silencing button and alarm reset button do not work.There was no patient involvement.The event date was not specified; estimate used.
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Manufacturer Narrative
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Date rec'd by mfr: 15feb2019.The manufacturer¿s international service technician confirmed the reported touchscreen issue.The service technician stated that when a panel button was operated, its reaction was occasionally poor.The manufacturer¿s international service technician replaced the touchscreen 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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Search Alerts/Recalls
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