Model Number GZ-130PA |
Device Problems
No Audible Alarm (1019); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2023 |
Event Type
malfunction
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Event Description
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The customer reported another instance where hi-q view ended for the gz transmitter.According to the customer, the batteries died in the transmitter and they never received a "low battery or change battery" alert on the central nurse's station (cns).There was no patient injury reported.
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Manufacturer Narrative
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The customer reported another instance where hi-q view ended for the gz transmitter.According to the customer, the batteries died in the transmitter and they never received a "low battery or change battery" alert on the central nurse's station (cns).The batteries the customer was using are procell constant.The customer will provide the logs to be reviewed.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: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.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 data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.
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Manufacturer Narrative
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Details of complaint: the customer reported another instance where hi-q view ended for the gz transmitter.According to the customer, the batteries died in the transmitter and they never received a "low battery or change battery" alert on the central nurse's station (cns).The batteries the customer was using are procell constant.The customer will provide the logs to be reviewed.There was no patient injury reported.Investigation summary: the batteries recommended in the operator's manual of the gz-130p are the only batteries that were verified to operate well with the device.Root cause has been identified as the use of non-specified batteries.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the gz transmitter: cns: manufacturer references # (b)(4).
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Event Description
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The customer reported another instance where hi-q view ended for the gz transmitter.According to the customer, the batteries died in the transmitter and they never received a "low battery or change battery" alert on the central nurse's station (cns).There was no patient injury reported.
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Search Alerts/Recalls
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