RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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Model Number V60 |
Device Problems
Thermal Decomposition of Device (1071); 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: 03apr2020.
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Event Description
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The customer reported unit was emitting an odor.Thermal damage to the (central processing unit) cpu board was observed.There was no patient or user harm was reported.
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Manufacturer Narrative
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Pma/510k: (b)(6) 2020.Date of report: (b)(6) 2020.The manufacturer's field service engineer (fse) confirmed the reported issue.Confirmed cpu pcba has burned components.The fse replaced the defective cpu and power management board to address the reported problem.The unit successfully passed the required performance verification test.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: 21sep2020.B4: 30sep2020.A cpu pcba (central processing unit, printed circuit board assembly) was returned for analysis.A visual inspection of the returned component was performed, and no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician confirmed the reported odor and damage.The root cause was determined to be the failure of the c165 component resulting in disposition of sediment across neighboring components.No fault was found with cpu (central processing unit) operation.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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