Device product
DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Z-0724-2023
Product summary
- Event
- Event 91112
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1004315 (US); 414559 (OUS)
- Official record key
device-enforcement:Z-0724-2023
Official wording
Reason: The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.
Code information: Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
Distribution pattern: US Nationwide. Foreign distribution pending.
Derived failure modes
-
Unknown
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.