RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 V60PLUS VENTILATOR |
Device Problem
Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
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 device was getting error code 1122 blower temperature high message.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped out with a different device.No medical intervention provided to the patient, nor a delay was noted.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse troubleshooting steps and advised the customer the latest version of the service manual is version t.Diagnostic code 1122- blower temperature high.The blower temperature was greater than 95ºc for longer than 60 seconds.Page 102 for referencing error code 1122 - blower temperature high.Verify that the air inlet filter is not dirty or blocked.Verify that the cooling fan is operational.Replace the blower.Replace the motor controller (mc) printed circuit board assembly (pcba) and provided parts id for a blower assembly for replacement.
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Manufacturer Narrative
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H10: after further evaluation, the customer was unable to duplicate the issue, no parts were replaced because it is believed that the reported issue was caused by an external factor, e.G.A curtain against the fans causing it to overheat.The device is back in service, and the unit is being monitored if it is to happen again.The device passed required performance verification tests per philips standards 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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