Model Number 0574-0195 |
Device Problems
Mechanical Problem (1384); Optical Problem (3001); Output Problem (3005)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2021 |
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 glidescope spectrum lopro s4, the blade did not have a working light during intubation.A delay in the procedure of an unreported duration occurred as a backup spectrum lopro s4 was obtained.No harm to the patient or user was reported.
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Manufacturer Narrative
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A replacement glidescope spectrum lopro s4 was provided to the customer.The spectrum lopro s4 used in the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the customer's returned spectrum lopro s4 and confirmed the reported led issue.The technical service representative reported that the spectrum lopro s4 failed to illuminate when connected to known, good, test equipment.The camera image quality test was performed and passed.The technical service representative attributed the illumination problem to an led issue.Since no repair is available for the glidescope spectrum lopro s4 and the customer was already provided a replacement, the returned spectrum lopro s4 was scrapped.Corrective action is not required at this time.Verathon will continue to monitor for trends.
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Search Alerts/Recalls
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