The customer reported when the nurse attempted to un-dock the x3 from the monitor, the nurse felt an electric shock in their arm that was holding the handle.The nurse went to the emergency department for evaluation.The device was in use on patient at time of event, there was no patient adverse event reported.There was an adverse event reported on a nurse.
|
Philips received a complaint on the intellivue mx550 patient monitor indicating that when the ward nurse tried to disconnect the x3 module from the mx550 monitor, the nurse was electrified at the handle on the arm holding the module handle, and subsequently ended up in the emergency department.It was provided that the nurse returned to work with an electrical shock mark on her arm, but there is insufficient information at this time to determine whether the event meets criteria for serious injury.The following functional tests were performed: the device was sent to bench repair.A bench repair technician (brt) evaluated the device and did not find any defects.An extended evaluation of both the mx550 and the x3, separately and used together, was done, and the brt found no issues with the devices in normal use.Both devices passed all tests including safety tests.Based on the information available and the testing conducted philips was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
|