- Firm Announcement Date:
- June 03, 2019
- FDA Publish Date:
- June 07, 2019
- Product Kind:
- Medical Gadgets
- Purpose for Announcement:
Recall Purpose Description
As a consequence of consumer error message leading to ventilator coming into into an ambient state
- Firm Title:
- Hamilton Medical AG
- Model Title:
- Product Description:
Hamilton Medical AG is updating all HAMILTON-G5 Ventilators (PN 159001 that accommodates the software program variations ≤ 2.60) with a newly developed software program model 2.80, to scale back the chance of the consumer message “Panel connection misplaced” and ventilator coming into an ambient state. The consumer error message is because of a blocked or terminated communication between the air flow unit processor and the interplay panel processor.
On February 11, 2019 and March 20, 2019, Hamilton Medical AG issued security communications to the customers for the Hamilton G5 Ventilators (PN 159001), as a result of “Panel connection misplaced” error.
Whereas there have been complaints as a result of consumer message error: “Panel connection misplaced”, no affected person harm or hurt had been reported. The consumer message error “Panel connection misplaced” can happen sporadically, and launch each a visible and an acoustical high-priority alarm to alert medical employees. In an occasion the consumer message error “Panel connection misplaced” happens, the HAMILTON-G5 ventilator can stop air flow and enter an ambient state. When the HAMILTON-G5 ventilator enters an ambient state, the next situations apply:
- The inspiratory channel and expiratory valves are opened, permitting affected person to breathe room air unassisted.
- Ventilator sounds a excessive precedence alarm with visible blinking LEDs alerting medical employees.
A Within the occasion of the error occurring, the HAMILTON-G5 Ventilator ceases air flow and enters an ambient state.
- Test and monitor your affected person for security.
- Present different air flow.
- Flip off the affected Hamilton G5 Ventilator.
- Contact your distributor (email@example.com) and have the HAMILTON-G5 Ventilator up to date with software program model 2.80
The investigation of the consumer message error “Panel connection misplaced” is as a result of blocked or terminated communication between the ventilator unit processor and the interplay panel processor resulting in the consumer error message “Panel connection misplaced” and ventilator coming into the ambient.
Please preserve this info along with your HAMILTON-G5 ventilators Operators Guide.
If you’re conscious of any incidents associated to this subject or when you’ve got any questions, please contact Hamilton Medical Inc. instantly at Tel. +1 775 858 3200, and/or e-mail: firstname.lastname@example.org, to offer info relating to these occasions so regulatory reporting obligations will be fulfilled.
Please preserve this info sheet along with your HAMILTON-G5 Ventilators Operators Guide.
We respect your assist on this matter and sincerely remorse any inconvenience that this motion might trigger you. We take into account this motion obligatory to make sure that our prospects obtain solely secure and efficient merchandise with prime quality.