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IVEA

Firefly Medical, Inc. · Model 600S · UDI-DI 00850003110103

FOX

510(k) clearances

434

Adverse events (5 deaths)

Recalls

293

Facilities

Description

IVEA is an innovative, 4-wheeled mobile patient equipment management device to aid the in-hospital ambulation process by organizing and mobilizing patient equipment when the patient is ready to ambulate. IVEA, designed by nurses to improve mobility, safety, efficiency, and storability, can replace the traditional IV pole and be set up at a patient’s bedside ready to move when the patient is ready. As a mobile equipment management tool, IVEA organizes and secures supportive equipment such as IVs, infusion pumps, oxygen tank, chest tubes, urinary catheters, drainage devices, PCAs, and feeding tubes, and eliminates the need to transfer equipment from one device to another for patient ambulation. IVEA can be set up before the patient arrives to reduce prep time at arrival and remain set up for every time the patient ambulates. IVEA makes it possible for fewer clinical staff to safely ambulate a patient. When not in use, IVEA folds and stores easily to reduce clutter.

Recalls

Date	Firm	Reason
2017-12-01	Ohmeda Medical	There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
2017-08-24	Firefly Medical, Inc.	The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deplo
2016-11-01	Firefly Medical, Inc.	The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
2016-08-22	EKOS Corporation	Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
2015-10-13	Stryker Medical Division of Stryker Corporation	It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated w

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.