Mediana Vital Signs Monitor May Fail to Power Up or Respond
Mediana AVSM3 SNF vital signs monitors may fail to power up or have unresponsive button controls, potentially preventing patient vital sign monitoring. The company is recalling 618 units distributed in Wisconsin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The device is classified as FDA Class II with no reported hospitalizations or injuries. However, a vital signs monitor that fails to power up or has unresponsive controls is a risk-of-harm product, as it could prevent critical patient monitoring. Score is High (3) per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Mediana Co., Ltd. is recalling the AVSM3 SNF vital signs monitor, a medical device used in hospitals and hospital-type facilities. The monitor is designed to track noninvasive blood pressure, oxygen saturation, pulse rate, and temperature in adult, pediatric, and neonatal patients.
In some cases, the equipment fails to power up and/or the key or button controls become unresponsive or stop working. This functional failure could prevent healthcare providers from obtaining or updating vital patient monitoring data.
The recall affects 618 units identified by serial numbers 460062000002 through 460062000501 and 460062100033 through 460062100150. All affected units were distributed in Wisconsin.
If your facility has affected units, contact Mediana Co., Ltd. or your healthcare equipment supplier for instructions on repair, replacement, or return of the device. Do not use affected equipment for patient monitoring until the issue is resolved.
The recalled product
- Product
- AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and…
- Manufacturer
- Mediana Co., Ltd.
- Affected units
- 618
Distribution
Distributed in 1 state:
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