Model Number 8015 |
Device Problems
Thermal Decomposition of Device (1071); Contamination (1120); Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no patient involvement associated for the reported failure as it was observed by the manufacturer during servicing activity.
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.H3 other text : see manufacturer narrative.
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Manufacturer Narrative
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Correction: annex d: (b)(6).Additional information: annex a: (b)(6).Annex c: (b)(6).Annex d: (b)(6).
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Event Description
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It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no patient involvement associated for the reported failure as it was observed by the manufacturer during servicing activity.
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Search Alerts/Recalls
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