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Catalog Number EMAX2PLUS |
Device Problems
Moisture Damage (1405); Overheating of Device (1437); Vibration (1674); Defective Device (2588); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Gtin is unavailable as the product made prior to compliance date; (b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device the reported condition was confirmed.It was determined that the issue was due to improper maintenance.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that the motor device had an undetermined malfunction.During the pre-repair diagnostics assessment, it was determined that the air pump was not functioning; the device was overheating, had excessive noise and vibration.It was further reported that the device was wet internally, which caused the motor to malfunction.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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