Catalog Number 05.001.202 |
Device Problems
Overheating of Device (1437); Device Inoperable (1663)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Event Description
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It was reported from (b)(6) that the power module device heated up when in use.As a result there was no power provided to the device for it to function.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any 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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Manufacturer Narrative
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Initial reporter¿s phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.A functional assessment was performed and no failures were identified.Therefore, an assignable root cause was not determined.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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