Catalog Number CON-EQ-5000HF-115V |
Device Problems
Overheating of Device (1437); Failure to Shut Off (2939)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the device is over temping and not shutting off.No patient injury was reported.Additional information was requested; however, no further information was received.
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Manufacturer Narrative
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A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi section is unknown, no product information has been provided to date.
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Manufacturer Narrative
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Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device presented with wear and tear damaged top and bottom enclosures.The customer stated problem was not duplicated.No device problem was found.No action was taken due to the age and condition of the device.It was deemed beyond economical repair and was scrapped.The cause of the reported problem could not be determined.A dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer reported problem were found during the review of service and repair records.
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Search Alerts/Recalls
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