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TFM Maintenance Kit 3040i

CNSystems Medizintechnik AG · Model V1.0 · UDI-DI 09120073930491

DXN

510(k) clearances

3,560

Adverse events (16 deaths)

Recalls

429

Facilities

Description

Set: 60_1: 2Stk., Pumpenlagerung Boden/Deckel, Eurofoam Protect, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.0 60_2: Pumpenlagerung Mittelteil, Eurofoam Protekt, KF55B1 weiß, Zuschnitt gemäß Zeichnung V2.0 60_3: Schaumstoffkleber, Foamspray 2203, 1000g Dose (für ContBP Pumpenlagerung) 60_4: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung) 60_5: Schwarzer, Rev 02, ContBP-Pumpe 7s52102 SP 600 EC-LC 12 V 60_6: PU-Schlauch DM6/4, 100m transparent (für Pumpe 0,215 ) 60_7: ContBP Pumpenkabel assembliert deakon 450_06: Schwarzer, 7K73051 Pumpe SP V 6TC27S RO-D 6VDC (für OszBP) 450_07: Kohritsu, SV-999, Solenoid valve 6V, DC 0,6W (Hauptventil für OszBP) 450_10: Zellkautschuk Stärke 6mm-7mm, schwarz, f. OszBP Pumpenlagerung, 25x25mm 450_11: Moosgummi Platte Stärke 2mm, grau, f. OszBP Pumpenlagerung (6V) 450_12: Kabelbinder natur, 144x2,5mm, Nylon 66 (für ContBP-Pumpenstutzen und OszBP Pumpenbefestigung) 450_13: Richmeg, RG-V-0520B, Solenoid valve (Backupventil für OszBP)

Recalls

Date	Firm	Reason
2025-02-24	PYRAMES INC	Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. C
2024-08-30	MEDLINE INDUSTRIES, LP - Northfield	It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30	MEDLINE INDUSTRIES, LP - Northfield	It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-08-30	MEDLINE INDUSTRIES, LP - Northfield	It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as
2024-03-26	Baxter Healthcare Corporation	Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26	Baxter Healthcare Corporation	Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-03-26	Baxter Healthcare Corporation	Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical s
2024-02-26	MEDLINE INDUSTRIES, LP - Northfield	The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. a
2021-05-17	Mediana Co., Ltd.	In some cases the equipment fails to power up and/or key or button unresponsive or not working.
2021-04-22	Welch Allyn Inc	Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock

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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.