RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problems
Failure to Shut Off (2939); Inadequate User Interface (2958)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E: (b)(6).
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Event Description
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Philips received a complaint by the customer on the v60 indicating that the touchscreen was not responding, and the device could not be turned off.It was reported that there was no patient involvement at the time the issue was discovered.Investigation is ongoing.
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Manufacturer Narrative
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H10: the customer called technical support to report that the touchscreen was not responding, and the device could not be powered down.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that the device could not be turned off and found that there was a problem with the motor controller (mc) printed circuit board assembly (mc pcba) after checking the logs.The asp engineer replaced the mc pcba and verified that 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.
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Search Alerts/Recalls
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