RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
|
Back to Search Results |
|
Model Number V60 |
Device Problem
Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
In a good faith effort (gfe) response from the authorized service provider (asp) was received, the asp stated that onsite service was completed.The abnormal noise of the ventilator had affected the patients rest.The asp engineer determined that the turbine clip of the ventilator was causing resonance, leading to the abnormal sound.After adjustment, the device was restored to normal function.The asp confirmed in the gfe response that there was no harm to the patients health.The investigation concludes that no further action is required at this time.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00314.All information from the original report(s) has been transferred to this report.
|
|
Event Description
|
Philips received a complaint by the customer on the v60 indicating that the device made an abnormal sound.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 investigation is ongoing.
|
|
Search Alerts/Recalls
|
|
|