Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
Device Problem
Corroded (1131)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Trackwise id# (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech have rust formation.No patient involvement.Related to (b)(4) (complaint 2 of 3).
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Event Description
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Summary: the hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech have rust formation.No patient involvement.
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Manufacturer Narrative
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Internal complaint number: (b)(4) the dhr shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The device was returned to the factory on 07/31/2020.Photographs were provided by the account.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion on the device itself.The trade name maquet engraved on the device as well as on the us patent engraving appeared to be brown resembling rust of corrosion.No other visual defects were observed.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion on the device itself.The trade name maquet engraved on the device as well as on the us patent engraving appeared to be brown resembling rust of corrosion.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.
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Search Alerts/Recalls
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