RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
|
Back to Search Results |
|
Model Number DSX520H11C |
Device Problems
Device Emits Odor (1425); Smoking (1585); Temperature Problem (3022)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/29/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3 other text : sent to a third-party service center.
|
|
Event Description
|
The manufacturer received information alleging the dreamstation 2 advanced auto cpap device.The patient alleges the device smells like burning smoke and is getting extremely hot.There was no report of patient harm or injury.During the evaluation of the device at the third-party service center, the device was visually inspected and found the unit is not working properly.In addition to the above findings, it was also determined that advance w/modem, dom, pca physical damage and service parts.The device was not repaired due to the customer requesting to scrap it.The manufacturer is submitting a final report at this time.
|
|
Manufacturer Narrative
|
The manufacturer previously received information alleging the dreamstation 2 advanced auto cpap device.The patient alleges the device smells like burning smoke and is getting extremely hot.There was no report of patient harm or injury.During the evaluation of the device at the third-party service center, the device was visually inspected and found the unit is not working properly.In addition to the above findings, it was also determined that advance w/modem, dom, pca physical damage and service parts.The device was not repaired due to the customer requesting to scrap it.The manufacturer is submitting a final report at this time.The manufacturer is submitting a correction for section h: problem code.
|
|
Search Alerts/Recalls
|
|
|