RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint from a philips medical device maintenance specialist (mdms) reporting the battery on the v60 ventilator could not charge.The device was not in clinical use.There was no report of harm.The mdms evaluated the device for field change order service activity and identified the battery would not charge.The mdms confirmed there was no battery failed alarm and the battery was older than 5 years of age.Per the philips v60 service manual, recommended timetable for battery replacement is every 5 years.The battery replacement is based on the date of manufacture recorded on the battery label.Also, the mdms reported the customer stored the unit without being connected to an alternating current (ac) power source.The v60 service manual advises the user the battery may fail to charge if stored for an extended period of time without the ventilator plugged into ac power.This issue was caused by use error.Per good faith effort response, it was confirmed that the battery will be replaced to resolve the reported issue once they receive the battery.Once replaced, the required performance verification tests per philips standards will be performed and will be returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Per v60 service manual: recommended replacement every 5 years based on the date of manufacture recorded on the battery label.
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