Model Number ZM-521PA |
Device Problems
Overheating of Device (1437); Structural Problem (2506); Temperature Problem (3022)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the transmitter got overheated.No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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It was reported that the transmitter got overheated.No consequence or impact to the patient.
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Manufacturer Narrative
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Correction data: f7: type of report.G7: type of report.H2: if follow up; what type? h6: method code, result code and conclusion code.H10: additional information: details of complaint: complaint states nkc technician performed case upgrades to telemetry transmitters that are getting reports of overheating.Service requested repair - rear case change.Service performed repair - rear case change.Investigation results upon investigation it was determined that 10 transmitters had rear cases replaced with upgraded cases for evaluation.Actual units were not overheating.The site has a history of units overheating with incorrect battery insertion.
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Manufacturer Narrative
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H10: additional narrative: complaint states nkc technician performed case upgrades to telemetry transmitters that are getting reports of overheating.Service requested repair - rear case change.Service performed repair - rear case change.Investigation results upon investigation it was determined that 10 transmitters had rear cases replaced with upgraded cases for evaluation.Actual units were not overheating.The site has a history of units overheating with incorrect battery insertion.Corrected information: f9.Approximate age of device: incorrectly calcuated.
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Event Description
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It was reported that the transmitter got overheated.No consequence or impact to the patient.
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Search Alerts/Recalls
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