RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint by the customer on the v60, indicating that the battery was not working and needed to be replaced.It was reported that there was no patient involvement at the time the issue was discovered.
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Manufacturer Narrative
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E1: (b)(6).
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Manufacturer Narrative
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The customer called technical support to report that the battery was not working and needed to be replaced.A field service engineer (fse) was dispatched onsite to evaluate and repair the device.Per good faith effort (gfe) response, the fse noted that the reported issue was confirmed-- the device could not turn on with only the battery and needed to be connected to electricity even after several minutes of charging.The fse also verified that the faulty battery was replaced, and the issue was resolved.The device passed the required performance verification tests per philips standard and was 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.Additionally, the fse mentioned that the defective battery was discarded.
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