Model Number MODEL 250 |
Device Problems
Failure to Interrogate (1332); Defective Device (2588); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2016 |
Event Type
malfunction
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Event Description
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It was reported that the medical professional was having communication problems with her programming system.It was reported that she could not interrogate generators when using the programming system.Troubleshooting was performed and the connection of the usb cable to the tablet was suspected to be at fault.Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.The return of the suspect usb cable is expected but it has not been received to date.
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Manufacturer Narrative
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Device manufacture date: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
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Event Description
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An analysis was performed on the returned usb to db9 cable and the reported allegation was verified.The cause for the reported allegation is associated with a disconnected wire connection in the returned serial cable.Once the wire was soldered onto the serial cable pcb, no further anomalies were identified.
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Event Description
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Additional information from a nurse indicated that the event occurred on (b)(6) 2016.The suspected usb cable was returned to the manufacturer on 08/19/2016.Analysis is underway but it has not been completed to date.
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Search Alerts/Recalls
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