The spot vs100 is intended for vision screening of subjects from the age of 6 months through adults.The device evaluates a subject¿s refraction, pupil size and visual gaze for determining the need for referral to for further evaluation.A medical (vision) professional.Spot vs100 is indicated for use when evaluation of individuals for poor vision and refractive errors is needed.The power cord has not been returned to hillrom for inspection.Therefore, an investigation into the root cause of the reported issue could not be performed.The customer was provided the part number for a replacement cord.Based on this information, no further actions are required at this time.If the unit would not power on it would be obvious to the user.If an alternate device was not available, the user would either reschedule the screening test when a device was available, or if testing could not be delayed, refer the patient to another facility where testing could be performed.Hillrom does not consider reports of a device not powering on to be a reportable malfunction.Although there was no reported injury with this event, if the report of a damaged power supply with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.
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