It was reported that the sensica device had an issue where the nurse could not push the button on the far left side of the monitoring screen to see previous hour data.They verified that to be an accurate assessment but noted that the rest of the buttons on the main monitoring screen were functional.Additionally, the nurse reported that the 2 previous hours showed zero output and also that the patient was away for those 2 previous hours even though the patient never left the room.Also noted that the temperature display was also no output (or) asterisks for the 2 hours that were shown as away.The nurse indicated that they removed and replaced the drainage tubing in the tube holder during the current hour and the unit started to register current output as well as the output that was missed for the previous 2 hours.They attempted to pull the log file from the unit but in doing so caused multiple reboots of the device, all reboots went right back into the monitoring session and did not lead to any loss of data.They obtained the log files from that unit for further investigation.
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It was reported that the sensica device had an issue where the nurse could not push the button on the far left side of the monitoring screen to see previous hour data.They verified that to be an accurate assessment but noted that the rest of the buttons on the main monitoring screen were functional.Additionally, the nurse reported that the 2 previous hours showed zero output and also that the patient was away for those 2 previous hours even though the patient never left the room.Also noted that the temperature display was also no output (or) asterisks for the 2 hours that were shown as away.The nurse indicated that they removed and replaced the drainage tubing in the tube holder during the current hour and the unit started to register current output as well as the output that was missed for the previous 2 hours.They attempted to pull the log file from the unit but in doing so caused multiple reboots of the device, all reboots went right back into the monitoring session and did not lead to any loss of data.They obtained the log files from that unit for further investigation.
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The reported event was inconclusive.No sample was returned for evaluation.The root cause of the reported issue could not be determined.A potential root cause is part geometry.However this could not be confirmed.They verified that to be an accurate assessment but noted that the rest of the buttons on the main monitoring screen were functional.All good faith attempts have been made to obtain additional information.The outcome of the repair could not be determined at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿general warnings.Medical electrical equipment requires special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in the charts at the end of these instructions for use (appendix a).Portable and mobile radiofrequency (rf) communications equipment can affect medical electrical equipment.The bd sensica¿ urine output system should not be stacked with other equipment.The bd sensica¿ urine output system has a degree of protection against electric shock of applied parts classified as type bf.This device is classified as an iec class i device.When using class 1 xp power model number: alm65us12 power supply, to avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, temperature sensor cables, or monoplug adapter in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor, cables or monoplug adapter.If liquids accidentally spill onto the device(s), wipe off liquid with soft cloth as soon as possible.See section 14 for complete care instructions.This device is not suitable for use in the presence of flammable mixtures.This device is not suitable for use in oxygen rich environments.The use of transducers and cables other than those specified, with the exception of transducers and cables sold as replacement parts, may result in increased emissions or decreased immunity of the bd sensica¿ urine output system.The bd sensica¿ urine output system is designed to be used with any bard¿ foley catheter and urological disposables connected to any standard urine drainage bag (2000 or 2500 ml), with or without a urine meter.If using a 400-series temperature-sensing foley catheter, see product instructions for use for mri compatibility.Refer to foley catheter instructions for use for indications and further product information.If using a 400-series temperature-sensing foley catheter, the operator is responsible for ensuring the compatibility of the temperature sensing foley catheter to the bd sensica¿ urine output system and its accessories.Incompatible components can result in degraded performance.No modification of the bd sensica¿ urine output system or any of its accessories is allowed.Warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.¿ h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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It was reported that the sensica device had an issue where the nurse could not push the button on the far left side of the monitoring screen to see previous hour data.They verified that to be an accurate assessment but noted that the rest of the buttons on the main monitoring screen were functional.Additionally, the nurse reported that the 2 previous hours showed zero output and also that the patient was away for those 2 previous hours even though the patient never left the room.Also noted that the temperature display was also no output (or) asterisks for the 2 hours that were shown as away.The nurse indicated that they removed and replaced the drainage tubing in the tube holder during the current hour and the unit started to register current output as well as the output that was missed for the previous 2 hours.They attempted to pull the log file from the unit but in doing so caused multiple reboots of the device, all reboots went right back into the monitoring session and did not lead to any loss of data.They obtained the log files from that unit for further investigation.
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