It was reported that the patient had a low voltage alarm while on mobile power unit (mpu) power.The patient's mpu cables and o-rings were inspected but no issues were observed.On (b)(6) 2020, the mpu had a biomedical engineering (bme) check with no issues identified, either.
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Manufacturer's investigation conclusion: the reported event of a low voltage advisory while connected to the mobile power unit (mpu) was not confirmed.The mobile power unit (mpu) was not returned for analysis; however, a log file was submitted for review with events spanning approximately 2 days ((b)(6)2020 per timestamp).There were no notable alarms active in the log file.Additional information received on (b)(6) 2020 stated that the customer confirmed the patient was on the mobile power unit (mpu) at the time of the reported low voltage advisory alarm.A root cause for the reported low voltage advisory alarms was unable to be conclusively determined through this analysis.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the low voltage advisory alarm conditions, and the actions to take if the alarms cannot be resolved heartmate 3 instructions for use (ifu) under section 3 ¿powering the system¿ explains the various ways to power the heartmate 3 lvas, including how to use the mpu.This section also informs the user to transfer from the mpu to another power source in the event of a power failure.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) caution users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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