Model Number ZM-530PA |
Device Problems
No Device Output (1435); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.The customer indicated that they will not be providing any additional information regarding the event.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
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Event Description
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The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.
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Event Description
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The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.
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Manufacturer Narrative
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Details of complaint: on 9/16/2019 customer submitted the log entry from the facility stating that "blood pressure and pulse-ox no longer on the monitor in the room." customer stated they could not provide any information regarding the entry note.Investigation conclusion: due to the lack of information available.An investigation into the reported issue is not possible at this time.No risk assessment could be performed.
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Search Alerts/Recalls
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