SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problem
Unexpected Shutdown (4019)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaint has been reported by the same us facility.The previous complaint evaluation for this serial number ((b)(4)) is: confirmed, root cause was identified as a motherboard and probe failure.(reference: mdr number 3006260740-2020-01733).Device not returned for evaluation.
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Event Description
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Per tm: keeps giving the ec111 error code, and shutting down randomly.It is doing it intermittently.Usually in transport, but sometimes in the middle of a picc.
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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, 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 ec111 error and unexpected shutdown was unconfirmed.The scanner ran for 24 hours powered on and did not exhibit the ec111 error code.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed one similar complaint from this serial number.The similar complaint has been reported by the same us facility.The previous complaint evaluation for this serial number (b)(6) is: 1.Confirmed, root cause was identified as a motherboard and probe failure.(reference: mdr number 3006260740-2020-01733) h3 other text : evaluation findings are in section h.11.
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Event Description
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Per tm: keeps giving the ec111 error code, and shutting down randomly.It is doing it intermittently.Usually in transport, but sometimes in the middle of a picc.
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Search Alerts/Recalls
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