Model Number ZM-531PA |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that this transmitter was intermittently displaying a pulse rate of 283.According to the customer, that this rate will be displayed on both the central nurse's station (cns) and on the transmitter's screen.There was no patient injury reported.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 this transmitter was intermittently displaying a pulse rate of 283.There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that this transmitter was intermittently displaying a pulse rate of 283.According to the customer, that this rate will be displayed on both the central nurse's station (cns) and on the transmitter's screen.There was no patient injury reported.Investigation summary: multiple follow-up requests were sent to the customer for additional information but they were unresponsive.A definitive root cause could not be determined since we could not confirm further troubleshooting or resolution details.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 09/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 09/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 09/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 09/01/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 09/07/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 09/13/2023 emailed the customer via microsoft outlook for device information: no reply was received.H10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.
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Event Description
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The customer reported that this transmitter was intermittently displaying a pulse rate of 283.There was no patient injury reported.
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Search Alerts/Recalls
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