RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
|
Back to Search Results |
|
Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ |
Device Problems
Defective Alarm (1014); Calibration Problem (2890)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).
|
|
Event Description
|
A customer was performing a post-use check in the hospital's clinical engineer room and found that a check vent alarm had occurred and contacted philips.The device was in clinical use at the time of the event however, there was no report of patient or user harm and neither delay in therapy nor medical intervention reported.The reported issue was not duplicated by a test run performed.Occurrence records of "check vent: primary alarm failed (diagnostic code:1102) (power speaker fail, motor speaker fail)" and "check vent: cpu pcba adc failed (diagnostic code:111e) were confirmed in the event log.The central processing unit (cpu) board and speaker#1 and speaker#2 were replaced to prevent recurrence.Unit was cleaned, run-in and functionally tested.
|
|
Manufacturer Narrative
|
A central processing unit (cpu) and 2 speakers were returned for failure analysis.An investigation was performed, and the returned cpu ran for extended period in power-cycled environment and no errors occurred.An investigation was performed on the returned speakers and the returned speakers operated normally on bench and in ventilator.There were no faults found on the returned parts.
|
|
Search Alerts/Recalls
|
|
|