Catalog Number 8065751763 |
Device Problems
Material Separation (1562); Inappropriate or Unexpected Reset (2959)
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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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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported the power switch was pulled half way out the machine.The system turned off and then turned back on during a surgical procedure.An alternate system was used to complete the surgical procedure.There was no harm to the patient.
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Manufacturer Narrative
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The company service representative examined the system and was able to confirm the reported event.The company service representative replaced the power entry switch, the power cord strain relief was replaced as a preventative measure (pm).The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported events can be attributed to a nonconforming power entry switch being pulled out of the system; however, how or when the power entry switch became nonconforming remains inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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