RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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Model Number V60 |
Device Problems
Device Alarm System (1012); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Event Description
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The customer called technical support (ts) reporting that the device's backup speaker is making high pitch noise, and also displays error code 1104 - backup alarm failed message within the event log.The customer reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.It was observed that there is an error code 1104 backup alarm failed message.Discussed the backup alarm circuit with the alarm on the central processing unit (cpu), powered by the motor controller (mc) printed circuit board assembly (pcba) and controlled by the power management (pm) pcba.The rse advised to replace the pm pcba as it controls if the speaker is on or off.Provided parts id for the pcba, power management, v60 - "new" 2nd gen to resolve the reported issue.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.
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Manufacturer Narrative
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Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.
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