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Model Number 284002 |
Device Problems
Improper Flow or Infusion (2954); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported by the customer in (b)(6) that during an arthroscopy surgery on (b)(6) 2021, it was observed that all the lights were on the fms vue pump device then stopped working.It was further reported that the pressure dropped to 1mmhg and the fill button started flashing on the device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 19-may-2021 and passed all functional testing before being returned to the customer.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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Manufacturer Narrative
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Per service report, additional information was received.It was reported that during service, there was liquid damage as water was found inside the machine, it was further reported that there was water damage on power supply and electrovanne assembly.All parts were replaced.It was reported that the main pcb was good and no need to change.I the internal enclosure of water residue was cleaned with full testing and verification were performed as well as the electrical safety which all passed.
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Search Alerts/Recalls
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