RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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) 2020.Date of report: 07/27/2020.
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Event Description
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During preventive maintenance, the device failed the proximal zero offset test.Patient involvement is unknown.
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Manufacturer Narrative
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G4: 10nov2020.B4: 11nov2020.The issue was discovered during preventative maintenance.The device was not being used for treatment and there was no patient involvement/harm when the reported event occurred.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: 27oct2020 b4: (b)(6) 2020 technical support advised the customer to replace the daq (data acquisition board) three good faith efforts were made to obtain all information.The customer did not respond to requests for additional information.If further information is obtained, a supplemental report will be submitted.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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