Details of complaint: the customer reported that the transmitter gave them a false reading of asystole after which their staff panicked and gave the patient medication to prevent a heart attack, which was not needed because the patient was not actually in asystole.There was no patient harm as a result of this incident.Investigation summary: as no devices were returned for evaluation relating to this event nor were any device logs provided for analysis, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Good faith efforts have been sent to the customer to obtain additional information, but the attempts have not resulted in additional information.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The cause of false alarming may be due to inaccurate data being recorded.Inaccurate data may be a result of device failure, hardware failure, poor patient prep, faulty leads, or poor lead placement.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt #1 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
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