SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number 9770600Y |
Device Problems
Charging Problem (2892); 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 12/07/2020 |
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 no other similar product complaint(s) from this serial number.Device not returned for evaluation.
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Event Description
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Per biomed, the power supply is functional, it works fine while plugged in then when you un-plug it, it may show 100% battery, but it powers off almost instantly.
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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 unit shuts down when not plugged into a/c power was confirmed.The unit shuts down when not plugged into a/c power.The root cause of the failure was identified as an internal failure within the lithium ion battery.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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Event Description
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Per biomed, the power supply is functional, it works fine while plugged in then when you un-plug it, it may show 100% battery, but it powers off almost instantly.
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Search Alerts/Recalls
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