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HomeMalsch GmbH › Care bed AURA

Care bed AURA

Malsch GmbH · Model 1 · UDI-DI 04065848000083

FNL
10
510(k) clearances
94,202
Adverse events (649 deaths)
155
Recalls
235
Facilities

Description

The medical care bed with electric drives is an advanced bed specifically designed for use in medical facilities such as hospitals, nursing homes, and rehabilitation centers. It offers a range of features and characteristics aimed at improving patient comfort, safety, and quality of care. Features and Specifications: Electric Height Adjustment - Adjustable Sleeping Surface - Integrated Side Rails - Integrated Control Unit - Robust Construction. The Care bed AURA provides a safe, comfortable, and functional solution for the care and treatment of patients in medical facilities. It complies with all relevant safety standards and regulations and helps make the caregiving process more efficient and effective.

Recalls

DateFirmReason
2026-05-04KAYSERBETTEN GMBH & CO. KGIf the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased ris
2024-09-18Baxter Healthcare CorporationThe beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
2023-08-30Stryker Medical Division of Stryker CorporationPatient beds are missing test values for electrical safety tests presenting risk of tissue burn or 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.