Model Number PARADYM 2 DR 8552 |
Device Problem
Inadequate User Interface (2958)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/15/2014 |
Event Type
malfunction
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Event Description
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Reportedly, during scheduled follow-up of the subject icd on (b)(6) 2014, the orchestra programmer screen froze; the programmer had to be unplugged and rebooted to resume the follow-up.An explanation is requested.
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Manufacturer Narrative
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The device model involved in this mdr report is not approved in the u.S.; however, it is similar to paradym rf dr models approved under p980049.
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Event Description
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Reportedly, during scheduled follow-up of the subject icd on (b)(6) 2014, the orchestra programmer screen froze; the programmer had to be unplugged and rebooted to resume the follow-up.An explanation is requested.
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Search Alerts/Recalls
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