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Model Number H21911 |
Device Problem
No Tactile Prompts/Feedback (4024)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 04/21/2023 |
Event Type
Injury
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Event Description
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During an atrial flutter procedure, the stimulator was unresponsive to a command to stop pacing resulting in the patient experiencing atrial fibrillation which required cardioversion to resolve the atrial fibrillation.The stimulator was turned off and rebooted and the issue was resolved with no further patient consequences.The physician was pacing down to a rate in the 200s, then the stimulator switched to pacing on channel 3 at 340 on its own.When the command to stop pacing was given via the keyboard, it did not stop pacing.It was attempted to stop pacing using the touchscreen but this was also unsuccessful.While this issue was occurring, the system and touchscreen displays showed a green stim bar, indicating the system did not think it was pacing, even though it was.The continued pacing caused the patient to be put into atrial fibrillation.The stimulator was turned off which stopped the pacing.The system was rebooted and the issue was resolved.Cardioversion was performed to resolve the atrial fibrillation.The procedure was completed with no other consequences.
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Manufacturer Narrative
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One ep-4¿ touch screen computer pn 600073636 and sn 18951737 was received into the lab for analysis.Visual inspection of the returned rf generator confirmed all input/output connector ports are free of physical damage, all labels are intact and legible, and normal wear was indicated on the chassis.The unit is having unexpected touchscreen input.Due to the state of the return, functional testing could not be performed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was unable to be determined due to the state of the return.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
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Search Alerts/Recalls
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