C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problems
No Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
Event Type
malfunction
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Event Description
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Per biomed: freezing up forcing a re-boot.
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Manufacturer Narrative
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The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluation for this serial number ((b)(4)) is: unconfirmed as the failure could not be reproduced during evaluation.(reference: mdr number 3006260740-2021-02702).
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Event Description
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Per biomed - freezing up forcing a re-boot.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, documents, labeling and applicable manufacture records.Based on a review of the information, the following was concluded: the site rite 8 was visually inspected upon receipt and was found to be in good physical condition.The reported issue is unconfirmed; clicked on the person icon then the pencil icon to enter patient info.All the fields were accessible.The reported issue is unconfirmed for freezing.Ran the scanner for 48 hours and it did not freeze during the entire test.There is no root cause due to the problems could not be duplicated.H3 other text : evaluation findings are in section h.11.
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Search Alerts/Recalls
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