Hamilton Medical Inc is recalling the Hamilton-C1, T1, and MR-1 ventilators as a result of the capacitators could leak electrolyte fluid onto the ventilator’s management board. If the management board contacts the electrolyte fluid, the management board or put in spare elements might quick circuit.
Because of the quick circuit, the ventilator could change to “ambient state.” A “realtime clock failure” might also seem on the display screen, and the person might be notified to set a date and time.
The “realtime clock failure” won’t have extreme results, however the “ambient state” failure would require speedy motion. “Ambient state” could require a well being care skilled to offer air provide to the affected person with a handbook resuscitating gadget and use one other ventilator. Critical harm or loss of life could consequence for sufferers who don’t breathe on their very own or don’t obtain speedy intervention.
There have been zero reported incidents, accidents, or deaths associated to this recall, in keeping with a recall discover on the US Meals and Drug Administration’s (FDA) web site.
The FDA has recognized this as a Class I recall, probably the most critical sort of recall.
- Product names: Hamilton C1, T1, MR-1 ventilators
- Product codes: See recall database entry
- Mannequin numbers:
- Hamilton-C1, REF: 161001, transportable intensive care ventilator
- Hamilton-T1, REF: 161006, intensive care and transport ventilator
- Hamilton-T1, REF: 161009, intensive care and transport ventilator
- Hamilton-MR1, REF: 161010, intensive care ventilator
- Hamilton C1/T1/MR1, REF: MSP161502/12, management board spare half
- Hamilton-T1, REF: MSP161339/02, ESM shielding set, spare half
- Distribution dates: July 28, 2020, to Aug 8, 2020
- Gadgets recalled within the US: 1,468
- Date initiated by agency: July 26
On July 26, Hamilton Medical despatched all affected clients an Pressing Medical System Correction letter. The letter requested clients to:
• Present various air flow instantly if the “ambient state” display screen seems.
• Swap off ventilator energy to exit the “ambient state.”
• Guarantee affected person security after which service the ventilator.
This recall is taken into account a correction as a result of the gadget might be returned to make use of after passing the service software program assessments.
Prospects with questions on this recall ought to contact Hamilton Medical at 1-800-426-6331 or e-mail [email protected].
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