Corrected data: device available for evaluation, device evaluated by manufacturer, manufacturer narrative.Additional information: establishment name, email address, address - line 1 and attn name in the address - line 2, city, state and post office.Name, email address, attn name in the address - line 2 and phone number.Type of report.Establishment name, email address, address - line 1 and attn name in the address - line 2, city, state and post office.Name, email address, address - line 1, address - line 2, city, state, post office and phone no.Continued email address and attn name in the address - line 2, and state.Type of report.Follow-up type.Event problem and evaluation codes.Manufacturer narrative: the customer reported that the transmitter overheats.The transmitter was removed from service and not used on a patient.The biomedical engineer tried testing the transmitter to see if the transmitter would get hot but was unsuccessful in duplicating the issue.Biomed notes that when the device was turned on it made a beeping sound and dashes were displayed on the transmitter screen.The unit no longer turns on.The customer was sent an exchange transmitter.The unit was externally cleaned and visually evaluated.The evaluation indicates the unit had fluid intrusion and is contaminated.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
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