RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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: 03sep2020.
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Event Description
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It was reported that the ventilator had an error alarm.There was no patient connected to the device at the time of the event occurred.
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Manufacturer Narrative
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G4:07jan2021.B4:08jan2021.Attempts were made to obtain further information regarding the device repair information.To date no further details have been received.The service history record was reviewed and no repair information was found.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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G4:08feb2021, b4:09feb2021.The field change order for the power management board has not been implemented.The hospital has the machines as a backup during covid-19.The hospital intends to defer the field change order implementation date.Field change order implementation is pending the customer's approval on the suitable time and date.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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Multiple attempts were made to follow-up with the customer to obtain repair information; however, there was no response.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.
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Search Alerts/Recalls
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