DEPUY SYNTHES PRODUCTS LLC POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE
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Catalog Number 05.001.202 |
Device Problem
Complete Loss of Power (4015)
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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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Udi: (b)(4).The reporter's facility address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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It was reported from (b)(6) that the power module device stopped working.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the light-emitting diode (led) warning light indicator was not working properly and was lighting up, the device was leaking liquid and the indicator on hall sensor was red.The device also failed pretest for check indicator ¿ liquid damage, function- test, charging and checking of power module in charger and information button & self-test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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