Model Number GZ-130PA |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that this unit is having sporadic communication loss (comm loss).Cits started the packet capture processes (pcaps) during a meeting to discuss the reported issue.The customer later requested to stop the pcaps as they were getting comm loss on all gz transmitters every two minutes.The system engineer stopped the pcaps as requested by the customer.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 01/25/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 01/30/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 02/06/2024 emailed the customer via microsoft outlook for patient information: no reply was received.D4 serial number.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: no.
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Event Description
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The customer reported that this unit is having sporadic communication loss (comm loss).There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that this unit is having sporadic communication loss (comm loss).Cits started the packet capture processes (pcaps) during a meeting to discuss the reported issue.The customer later requested to stop the pcaps as they were getting comm loss on all gz transmitters every two minutes.The system engineer stopped the pcaps as requested by the customer.There was no patient injury reported.Investigation summary: cits started the packet capture processes (pcaps) during a meeting to discuss the reported issue.The customer later requested to stop the pcaps as they were getting comm loss on all gz transmitters every two minutes.The system engineer stopped the pcaps as requested by the customer.As the communication loss was occurring on multiple gz devices at the same time, it is unlikely that the gz devices themselves were malfunctioning; a root cause could not be determined.D4 serial number.H4 device manufacturer date.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h11 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 unit is having sporadic communication loss (comm loss).There was no patient injury reported.
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Search Alerts/Recalls
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