RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
|
Back to Search Results |
|
Model Number V60 V60PLUS VENTILATOR |
Device Problem
Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
G1 contact office phone: (b)(6).
|
|
Event Description
|
Philips received a complaint on the v60 ventilator indicating that there was a 35 volt failure during setup of the device.The device was reported to be outside of use at the time of the reported problem.No patient or user harm reported.It is believed that the 35 volt failure is a result of a power management (pm) printed circuit board assembly (pcba) failure.This investigation is ongoing.
|
|
Manufacturer Narrative
|
H10: multiple good faith efforts (gfe) were attempted on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024 to obtain confirmation of the part order, part replacement, and resolution.No response or further information was received from the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
|
|
Search Alerts/Recalls
|
|
|