RESPIRONICS CALIFORNIA, INC BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
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Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Implant date: (b)(6) 2021.Explant date: (b)(6) 2021.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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Event Description
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The customer called into technical support (ts) reporting that the device¿s battery failed.The customer reported there was no patient involvement at the time the issue was discovered.
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Manufacturer Narrative
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G4:17feb2021.B4:04mar2021.H10: the device was in clinical use when the reported issue was discovered; however, there was no harm to the patient or user.There was no patient therapy delay.The service work order was cancelled.The customer has decided not to repair the device at this time.The device is ¿end of life.¿ the device is being removed from service.Philips no longer support accessories, supplies, upgrades, and repair support parts associated with the bipap focus.The end of support date for bipap focus ventilator is 31st december 2019.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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