Model Number ZM-531PA |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.The customer device has not yet been received.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 a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.
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Manufacturer Narrative
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The customer reported that a nurse noticed a transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.On 07/26/2016 nihon kohden followed up with the customer.The customer states they are going to send the device and batteries as well as their incident report.The customer device has not yet been received.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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Manufacturer Narrative
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The customer reported that the transmitter stopped transmitting data.When the staff went to check on the patient it was noted that the transmitter was getting very hot on a patient.Patient was not harmed and is stable.The biomedical engineer received the transmitter within minutes of the nurse discovering the hot unit.The biomedical engineer tested the unit and confirmed it still worked.In the process he found what had caused the transmitter to get very hot.He advised the batteries had started to come apart and leak, this started melting the transmitter battery bay.The hospital is writing up an event for this complaint.Nihon kohden sent the customer an exchange and instructed the biomedical engineer to send in his unit once the hospital is complete with their investigation.The hospital will include their documents on the complaint with the damaged unit they are sending back.On (b)(6) 2016 nihon kohden followed up with the customer.The customer states they are going to send the device and batteries as well as their incident report.As of (b)(6) 2016 the customer device has not yet been received at nihon kohden america.The device was received by nihon kohden on (b)(6) 2016 and evaluated.It was confirmed that the battery compartment casing was melted and deformed.Additionally, the spring in the battery compartment was bent upward and the battery was leaking.The conclusion of the investigation is that the bent spring was caused by the customer incorrectly inserting the batteries into the device.This caused the spring to rupture the battery label jacket.When the label jacket ruptured, the positive electrode (outer casing) contacted the negative electrode via the spring, which produced a short circuit.A large current in the spring created excessively high temperatures and disrupted monitoring of the device.The high temperature caused the battery compartment to melt, deform, and leak as observed in the device and batteries provided to nihon kohden by the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if any additional information becomes available.
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Event Description
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The customer reported that the transmitter stopped transmitting data.When the staff went to check on the patient it was noted that the transmitter was getting very hot on a patient.Patient was not harmed and is stable.
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Search Alerts/Recalls
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