Model Number W4TR01 |
Device Problems
Incorrect Measurement (1383); Unable to Obtain Readings (1516)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2018 |
Event Type
malfunction
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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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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 the cardiac resynchronization therapy pacemaker (crt-p) had an ¿invalid data¿ displayed for cardia compass data.The invalid data will clear from the device with no action needed by the clinician.The device is still in use.No patient complications have been reported as a result of this event.
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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 cardiac compass data was 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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