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It was reported by the customer that an eli 230 with a damaged power cable would not charge and shocked a user.The customer has been unable to identify the individual who reported the event.Follow-up attempts were made with the customer; however, they could not provide any further details of level of injury, medical intervention (if any), and outcome.The customer confirmed there has been no recent report by an employee due to a shock received at their facility, therefore, they believed this to be a minor shock event.This report was filed in our complaint handling system as c-(b)(4).
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It was reported by the customer that an eli 230 with a damaged power cable would not charge and shocked a user.The customer has been unable to identify the individual who reported the event.Follow-up attempts were made with the customer; however, they could not provide any further details of level of injury, medical intervention (if any), and outcome.The customer confirmed there has been no recent report by an employee due to a shock received at their facility, therefore, they believed this to be a minor shock event.The eli 230 is a multi-channel electrocardiograph product used for acquiring, viewing, and printing resting ecg¿s.The eli 230 is a 12-channel diagnostic electrocardiograph intended for recording and printing ecgs of adult and pediatric patients.The device is not intended to be used as a vital signs physiological monitor.The eli 230 is intended to be used by a licensed health care practitioner in a hospital or clinical setting.It is designed to be used for acquiring, viewing, and printing resting ecg¿s.The eli 230 is a standard 12-lead, electrocardiograph that is intended to be used with the welch allyn wireless acquisition module (wam) or welch allyn acquisition module (am12) patient cables.The device user manual notes the following cautions with damaged equipment/ components: damaged or suspected inoperative equipment must be immediately removed from use and must be checked/repaired by qualified service personnel prior to continued use.The device user manual notes the following warnings regarding shock: medical devices have been designed to have a higher degree of protection against electric shock than, for instance, information technology equipment because patients often are connected to multiple devices and may be more prone to the adverse effect of electric currents than healthy persons.All equipment that is connected to the patient, can be touched by the patient, or can be touched by another person while that person touches the patient at the same time, should have the same level of protection against electric shock as medical equipment.The eli 230 is a medical device that has been designed to be connected to other devices for the purpose of receiving and transmitting data.Certain measures must be taken to prevent the risk of excessive electric current flow through the operator or patient when connected: all electrical equipment that is not medical electrical equipment must be placed outside of the ¿patient environment,¿ defined by applicable safety standards to be at least 1.5 meters (5 feet) from the patient.Alternatively, non-medical equipment may be provided with additional protection such as an additional protective earth connection.All medical electrical equipment that has a physical connection to the eli 230 or the patient or is in the patient environment must comply with applicable safety standards for medical electrical devices.All electrical equipment that is not medical electrical equipment and has a physical connection to the eli 230 must comply with applicable safety standards, such as iec 60950 for information technology equipment.This includes information network equipment connected through the lan connector.Conductive (metal) parts that can be touched by the operator in normal use and that are connected to non- medical equipment should not be brought into the patient environment.Examples are connectors for shielded ethernet or usb cables.If multiple devices are connected to each other or to the patient, device chassis and patient leakage currents may be increased, and should be measured for compliance with applicable standards for medical electrical systems.Avoid the use of portable multiple socket outlets.If used and not compliant with medical electrical device standards, an additional protective earth connection is required.To prevent electric shock due to unequal ground potentials that may exist between points of a distributed network system or fault conditions in external network connected equipment, network cable shielding (where used) must be connected to protective earth ground appropriate to the area where the device is used.Inspection of the device by the hillrom service team found the reported issue of an operator being shocked as not verified and unable to determine.The device iec connector was observed by the service team as chipped around the edges and the solder joints were additionally noted as broken.The reported problem of the device not charging was due to the dead battery and broken power supply.During the device functional check, it was noted there was a missing print due to faulty printhead assembly.Additionally, it was reported that the device had cracked, and broken buttons and the service team notes this as possible due to use of abrasive cleaning supplies.Attempts to obtain additional details to determine severity of the event including injury, medical intervention provided (if any), employee outcome, and how the event occurred were unsuccessful.The event of shock to an employee likely occurred due to the broken power supply, additionally note by the customer, but this could not be confirmed during device inspection.Procedures for prevention of shock are outlined in the device user manual as noted above.The customer did not provide the necessary information to determine the severity of injury, however, due to the potential for serious injury if this event were to recur, hillrom is cautiously reporting this event.
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