Model Number 865071 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
Injury
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Event Description
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The customer requested documenting concerning (b)(4) or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco (b)(4) in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.It is unknown if the device was in clinical use.The report was marked as patient harm.The nature of the harm was not provided at the time of this report.
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Manufacturer Narrative
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A follow-up report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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H3 other text : no alleged product malfunction.
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Event Description
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After further investigation, this complaint was deemed not a reportable event with philips.The customer requested documentation concerning fco86201075a or service history of a fco being applied to the device in question.A philips product support engineer (pse) provided another fco 86201218a in which the serial number was listed on the can application layer (cal).A philips regional service manager (rsm) followed up with customer, and told them philips will continue to research the request and that the initial fco was for an addendum to the instruction for use ifu.At the time of the follow-up investigation, the customer indicated they wanted to be transparent that the reason why they are asking for the documentation was due to pending litigation.The customer confirmed that there was no patient harm associated with this request.The customer was requesting the service history regarding the involved device.
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Search Alerts/Recalls
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