Manufacturer's investigation conclusion: the report of an electric shock sensation could not be confirmed.Furthermore, a direct correlation between the device and the reported event could not be conclusively determined through evaluation of the submitted log file.It was reported that the patient was sitting in their chair on (b)(6) 2022 and felt multiple electric shocks near their pump.They had never experienced a sensation like this before.The patient did not notice any ventricular assist device (vad) alarms and had no other associated symptoms.The submitted controller event log file captured no atypical events or alarms.The system appeared to operate as intended at the set speed for the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 (hm3) left ventricular assist system (lvas), serial number (b)(6), and no further issues have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 25sep2018.Heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) and heartmate 3 lvas patient handbook are currently available.The hm3 lvas ifu and patient handbook warn that if the external system components have contact with water or moisture, the patient may receive an electric shock.Section 4 of the heartmate 3 lvas patient handbook includes information on static electricity and recommends patients to use battery power instead of the mobile power unit (mpu) while not sleeping or resting to reduce the risk of system damage from high levels of static electricity.The patient handbook also instructs patients to call their hospital contact if they think that, for any reason, any portion of their equipment is not functioning as usual, is broken, or if they are uncomfortable with the operation of the equipment.No further information provided.The manufacturer is closing the file on this event.
|