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Model Number ASSY, AMI 9700 CONSOLE |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/15/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This product has not been received back for evaluation at the time of this report.The problem cannot be confirmed.If the suspect device is returned a supplemental report will be issued with the results of the evaluation.Additional part used: assy, probe, ami 9700 (pre-copq); catalog: 0570-0309; sn: (b)(4).
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Event Description
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The customer reported that the assy, ami 9700 console with assy, probe, ami 9700 (pre-copq) did not perform as intended during a patient procedure.The customer reported that the probe was giving inaccurate readings.No patient or user harm reported.
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Search Alerts/Recalls
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