Model Number W4TR01 |
Device Problems
Inappropriate or Unexpected Reset (2959); Reset Problem (3019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that there was an electrical reset on the device.The device remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a full electrical reset.Analysis of the device memory indicated that the atrial and ventricular rate histogram data were missing/invalid.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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