RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problems
Device Alarm System (1012); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: g: phone: (b)(6).
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Event Description
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Philips received a complaint from the customer, reporting that the v60 ventilator had a battery issue.There was no patient involvement when the issue occurred.No patient or user harm reported.Investigation is ongoing.
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Manufacturer Narrative
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A follow up was performed with the key market, and it was reported that the device had a 1115 error code (check vent: auxiliary alarm supply failed), and that the device did not have a battery issue.The km responder reported that the customer declined to have the device repaired by philips.Insufficient information is available to determine the resolution of the event.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.
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Search Alerts/Recalls
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