A durable medical equipment (dme) supplier reported that an infant apnea monitor did not alarm during a cyanotic and apneic pt event on (b)(6) 2010. The dme reported the infant was not spontaneously breathing and the caregiver initiated cardiopulmonary resuscitation (cpr). The infant was transported to a hospital and was reported to require mechanical ventilation. The apnea monitor was retrieved from the pt's home by the dme and sent to the mfr for investigation. The mfr evaluated the device and did not confirm the allegation that the monitor did not alarm. The apnea monitor was visually examined and tested by the mfr using a simulator in accordance with the smart monitor 2 checkout procedure manual (pn 1020818). The apnea monitor detected and alarmed appropriately for simulated events and passed all required testing. The apnea monitor's memory data was downloaded and analyzed by trained associates. The downloaded memory revealed the apnea monitor was in use in the home from (b)(6) 2010 and that there had been 314 pt events recorded during that time. All recorded pt events were associated with audible and visual alarms. The memory data also showed the apnea monitor recorded five (5) 'loose lead' equipment events and six (6) pt events that would have all prompted an audible alarm on the day of the alleged event. The dme stated that a checkout procedure was performed prior to the monitor being placed into use on the infant and the device passed all required testing at that time. The smartmonitor 2 was set up with a 16 second delay before recording apneas and a 20 second delay before annunciating and recording an alarm for an apnea condition. Based on the monitoring data downloaded from the device, seventeen (17) pt events met the criteria for annunciating an apnea alarm on the date of the alleged adverse event. The smartmonitor 2 was programmed with parameters that were appropriate for recording and alarming for respiration and heart rate events during infant monitoring. The smartmonitor 2 device is not intended to be used to monitor pts for cyanosis and has no capability to do so. The smartmonitor 2 parents' guide (pn 572-4000-00) states in the indications for use: 'the smartmonitor 2 is intended for use in continuous monitoring of heart rate and respiration of infant pts in a home, hospital or portable environment. Its primary function is detection of central apnea. Its secondary function is measurement of heart rate. The smartmonitor 2 device is not intended to prevent loss of breathing or heart activity. The smartmonitor 2 parents' guide (pn 572-4000-00) further states: the smartmonitor 2 is a monitoring device only. It does not prevent the loss of breathing or heart activity, nor will it restore breathing or heart activity. It will not prevent death. Anyone using the smartmonitor 2 to monitor an infant should be trained in current infant cardiopulmonary resuscitation (cpr), which is a proper way to restore breathing and heart activity. ' there was no report of permanent harm or injury, and the mfr was not able to confirm the allegation of alarm failure during a pt event. The monitor passed all required testing and detected and alarmed appropriately for simulated events. Based on all available info, the mfr concludes that the device does function to specification and that no further action is appropriate.
- Respironics Smart Monitor 2 Manual
- Smartmonitor 2 Respironics
- Respironics Smart Monitor 2 Clinical Manual
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- User Manual Quickstart Guide C-F le x. Note: If any of the above items are missing, contact your home care provider. 1-2 REMSTAR AUTO M SERIES USER MANUAL 1.2 INTENDED USE The Respironics REMstar Auto M Series system is a CPAP (Continuous Positive Airway Pressure). A warning indicates the possibility of injury to the user or the.
- Respironics Smart Monitor 2 Clinical Manual However, the hidden-pointer function can be set in Windows, and the second function can actually slow your work. Infant respiratory SmartMonitor and NeoPap product lines for an undisclosed development at Respironics before it was acquired by Philips in 2008 for $5 billion.
User/Owner Responsibility This Respironics equipment and the authorized accessories are designed to work as described in the operator's manual. The user(s) of this equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. The monitor and its accessories should not be modified.
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Respironics Smart Monitor 2 Manual
Smartmonitor 2 Respironics
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Respironics Smart Monitor 2 Clinical Manual
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