BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number H749ILAB100C270 |
Device Problem
Retraction Problem (1536)
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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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(b)(4).
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Event Description
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It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a sled to perform automatic pullback.However, it was unable to perform pullback.Thus, automatic pullback failed.Furthermore, no problem was encountered during testing now.Recently, pullback often stops.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.The product was received in good condition with no visible external damage or defects observed.The mdu-5plus was installed into a gold standard system and tested for functionality.The unit meets specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a sled to perform automatic pullback.However, it was unable to perform pullback.Thus, automatic pullback failed.Furthermore, no problem was encountered during testing now.Recently, pullback often stops.No patient complications were reported.
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Search Alerts/Recalls
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