RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Material Discolored (1170); Device Emits Odor (1425)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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: 10mar2020.
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Event Description
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The philips service engineer (fse) identified during preventive maintenance that there was an odor and a tarnished connector.The philips service engineer (fse) confirmed the reported failure.The unit was not in clinical use at the time of the reported problem, and no patient or user was harmed.
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Manufacturer Narrative
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G4: 23jul2020.B4: 06aug2020.H11: b1:h1: updated: this complaint has been re-assessed.The ventilator was immediately turned off, removed from patient¿s room.No harm occurred.There was no report of medical intervention being required as a result of this event.Based on this information, the type of reported event has been updated to non-adverse event.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: 09mar2020.B4: 27mar2020.The philips service engineer (fse) replaced the cable, harness, power, v60.Fse performed all required tests per philips' manual.Unit passed all tests successfully.The unit has returned to service mode.G4: 25mar2020 b4: 27mar2020 h10: b1 and h1 updated the customer confirmed the v-60 was in operation when an electrical burning smell was noted by the registered nurse (rn).The v60 was immediately turned off and removed from patient¿s room.No patient harm occurred.Numerous attempts were made to obtain patient information but unsuccessful.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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