RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Communication or Transmission Problem (2896)
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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) 2018.Date of report: 22jul2019.Product support engineer (pse) troubleshot this issue with the customer over the phone.Customer did not install serial number before attempting to access respilink.Pse provided respilink installation guide.Customer reported they refreshed respilink and it populated with the software options.The serial number was provided and the service history record for this device was reviewed for similar symptoms.No relevant symptoms were found in the device service history record.No device malfunction.The issue is with the external device.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
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Event Description
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The customer reported unable to connect to the respi-link remote diagnostic system.There was no patient involvement.
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Manufacturer Narrative
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Upon secondary review it was determined this issue was reported in error.It is not a malfunction of the device and would not pose a risk of death or serious injury to a patient or end user if it were to reoccur.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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