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Catalog Number 9770066 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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Event Description
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Biomed reported end users complained of the sr6 ultrasound image being out of alignment, although the issue could not be confirmed when biomed was testing the system with tech support.
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Event Description
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Biomed reported end users complained of the sr6 ultrasound image being out of alignment, although the issue could not be confirmed when biomed was testing the system with tech support.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of ultrasound out of alignment was unconfirmed.The needle tracking image is properly aligned.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar complaint(s) from this serial number.
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Search Alerts/Recalls
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