Model Number 0800-0543 |
Device Problems
Break (1069); No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
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Event Description
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The customer reported that during a patient procedure, using a spectrum smart cable, the cable's connector broke off in the middle of the intubation.Though questioned, the customer could not specify which connector end broke off.The procedure was completed using another spectrum smart cable which was made available in an unspecified amount of time.No harm to the patient or user was reported.
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Manufacturer Narrative
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A replacement glidescope spectrum smart cable was provided to the customer and the spectrum smart cable used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned spectrum smart cable and confirmed that the cable was missing the hdmi connector.No indication was provided as to how the hdmi connector became separated from the cable.Since the customer had already received a replacement glidescope spectrum smart cable, the returned device was scrapped.No corrective action is required at this time.Verathon will continue to monitor for trends.
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Search Alerts/Recalls
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