RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Defective Device (2588); Protective Measures Problem (3015)
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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) 2020.Date of report: 20jul2020.
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Event Description
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It was reported that the ventilator had a check vent alarm - primary speaker failed.There was no patient involvement.The service engineer (se) inspected the device.The se found the primary speaker failed with error code indicating primary alarm failed.The se replaced the speaker and central processing unit (cpu) board.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.
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Manufacturer Narrative
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The central processing unit (cpu) was returned for analysis.Visual inspection was performed, and no anomalies were noted.An investigation was performed, and the product analysis technician reported that no fault was found.
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Search Alerts/Recalls
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