Model Number 8120 |
Device Problems
Crack (1135); Failure to Analyze Signal (1539); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The actual date of event is unknown.Device evaluated by bd service.A review of the complaint history for sn (b)(4) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 27may2016.The review was performed from the date of manufacture to the present date (b)(6) 2021.A review of the device history record for sn (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record for sn (b)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.
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Event Description
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It was reported that the device had rattling noise inside.There was no patient involvement.
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Manufacturer Narrative
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Correction : unique identifier (udi) #.
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Event Description
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It was reported that the device had rattling noise inside.There was no patient involvement.
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Search Alerts/Recalls
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