[11098]
On 1/13/94 prior to installed and programmed 16 bed new telemetry system. On 1/15/94 at 0610 monitor watcher noticed that #14 & #15 monitors were exhibiting similar arrythmias simultaneously. Charts were reviewed for #14 & #15 and it was determined that patient's in #14 strips were identical to that of patient in #15 since time of #14's admission to the unit which was 1/13/94 at 1545. #14 patient was placed on separate externa monitor to verify that this was not his correct rhythm. Monitor watcher notified manufacturer at 0625 on 1/15/94. She was instructed by manufacturer on how to reprogram the correct frequency for channel 14. On 1/15/94, biomed department in a. M. Verified that all frequencies were correct and notified manufacturer of this. On 1/17/94 biomed department again verified that all frequencies were correct for channels 9 thru 16. Manufacturer was again notified and biomed obtained a list of frequencies and they again verified that all frequencies were programmed into the computer correctly. Per request of manufacturer biomed powered system down and powered system back up and verified that frequencies stayed as programmed. On 1/20/94 at 0715 monitor watcher noted that patient on telemetry #7 was taken off the monitor and at exact same time telemetry #14 demonstrated loss of ecg waveform not correctable by electrode change or battery change. Patient was placed on an external monitor from this system at 0756 and strip was run. At 0850 channel 14 turned on and displayed a wave form prior to telemeter #14 being placed placed on the patient. It was noted that #14. Strips were compared for patients #7 and #14 and it was determined that strips were same since 0700 on 1/19/94. Monitor watcher was interviewed and noted she did not go thru screens to switch auxiliary mode nor to the best of her knowledge did any staff. Manufactur was notified of this event at 10:15 a. M. Device not labeled for single use. Patient medical status prior to event: invalid data. There was multiple patient involvement. Number of patients involved: 2. Invalid data - on device service/maintenance. Date last serviced: 01-jan-94. Service provided by: distributor. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, computer software performance tests conducted. Results of evaluation: other. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device use continued with restrictions/limitations. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5