Model Number GZ-120PA |
Device Problems
Power Problem (3010); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2021 |
Event Type
malfunction
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Event Description
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The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.
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Manufacturer Narrative
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The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.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 biomedical engineer (bme) reported that the gz telemeter's battery contact was broken, causing it to intermittently lose power.
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Manufacturer Narrative
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Details of complaint: the biomedical engineer (bme) reported that the gz telemeter's battery contact was broken, causing it to intermittently lose power.No patient harm or injury was reported.Investigation summary: the device was also missing the battery cover.Damaged battery contacts are the result of forcibly inserting batteries as stated in the hazard document (b)(4).The actions taken in designs are: device is equipped with a torsion spring to minimize terminal damage / deformation, device is equipped with over current protection in case battery is inserted incorrectly, design of the battery compartment in which the battery cannot be inserted in the opposite polarity, attached a sign that indicates the direction of batteries.The actions taken in labelling include: shows a figure of how to insert the batteries.The battery cover is securely attached to the gz transmitter via a flexible strap.The cause of the damage could not be determined.Given the damage reported on the battery contacts, it is presumed that the device was handled roughly.The service history for this gz device shows this is an isolated incident with no recurrence history for this device.
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Search Alerts/Recalls
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