Model Number D2201 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2019 |
Event Type
malfunction
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Event Description
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It was reported that prior to a procedure the product cardboard box was found to be unsealed.The plastic top was not sealed, and the device cords were tangled and disorganized.The device was not used.The patient had not been sedated when the issue was discovered and the procedure was rescheduled.
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Manufacturer Narrative
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The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Only the device was received.The device packaging was not returned for analysis so the reported allegation could not be confirmed.The information provided is not sufficient to assign a cause, therefore, an evaluation conclusion code of no problem detected was assigned to this investigation.
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Event Description
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It was reported that prior to a procedure the product cardboard box was found to be unsealed.The plastic top was not sealed, and the device cords were tangled and disorganized.The device was not used.The patient had not been sedated when the issue was discovered and the procedure was rescheduled.
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Search Alerts/Recalls
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