| Class 3 Device Recall HAMILTONH900 |  |
Date Initiated by Firm | January 05, 2021 |
Create Date | July 14, 2022 |
Recall Status1 |
Completed |
Recall Number | Z-1385-2022 |
Recall Event ID |
90460 |
510(K)Number | K163283 |
Product Classification |
Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
|
Product | HAMILTON-H900 Humidifier, Models: 950001, 950004 |
Code Information |
UDI:07630002801546. All devices with software version 1.10c |
Recalling Firm/ Manufacturer |
Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland
|
For Additional Information Contact | 41816606010 |
Manufacturer Reason for Recall | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber. |
FDA Determined Cause 2 | Employee error |
Action | On 01/05/21, Field Safety Corrective Action notices were sent to customers who were asked to do the following:
Follow the instructions in the HAMILTON-H900 Operator s Manual 624431 section 3.4.
Before connecting a new patient to the humidifier;
" Verify that the alarms operate correctly.
" Ensure that the water supply to the humidifier chamber is functioning properly.
Distribute this notification to all end users within your organization.
A Medical Representative will be in contact to schedule service with a software update.
Customers with additional questions or concerns were encouraged to call Technical Support at 1-800-426-6331, option #2. |
Quantity in Commerce | 203 |
Distribution | US: WI, FL, CA, NV, PA, TX, PA |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
|
510(K) Database | 510(K)s with Product Code = BTT
|
|
|
|