Model Number 8300 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371); Noise, Audible (3273)
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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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This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.A review of the source device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
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Event Description
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(b)(4).
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Manufacturer Narrative
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This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.A review of the source device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.A review of the device history record in sap for sn (b)(6) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(6) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
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Event Description
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Noisy replaced broken right iui.There is no patient involvement.(b)(6)2019 11:36:46 (b)(6)the ferrite bead came off from ty wrap and makes a rattle sound when unit is shaken.(b)(6) 2019 12:59:58 (b)(6).
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Search Alerts/Recalls
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