Model Number R SERIES |
Device Problems
Erratic or Intermittent Display (1182); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device's display intermittently blanks out.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Device evaluation: the device was returned to zoll medical corporation; the customer's report was observed and attributed to a faulty integrated circuit on the digital board.The digital board was replaced to resolve the report.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device restarted/rebooted itself multiple times.
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Search Alerts/Recalls
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