Model Number 00-3020 |
Device Problems
Circuit Failure (1089); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/04/2021 |
Event Type
Death
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Event Description
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The incident described as follows by the customer - patient was 2 years old male (dob:(b)(6) ) asystole on arrival.Adult pads were used and would work for 25-30 sec and then ecg tracing would disappear, and work for 25-30 sec.¿changed pads and they worked fine rest of call¿ patient pronounced dead at hospital.
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Manufacturer Narrative
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A user report was received related to a reported patient death which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received and investigation has progressed.
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Event Description
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The incident described as follows by the customer - patient was 2 years old male (dob: (b)(6) 2018) asystole on arrival.Adult pads were used and would work for 25-30 sec and then ecg tracing would disappear, and work for 25-30 sec.¿changed pads and they worked fine rest of call¿ patient pronounced dead at the hospital.The device arrived at the manufacturer schiller on 05 july 2022.No device failure was detected during the entry test.The device passed all tests successfully.No failure could be found.On evaluation of the device it is found that defibrillator pads were connected to the tempus ls manual.The defibrillator pads were then placed on a person.The device was started and an ecg signal was visible.It was not possible to reproduce the described issue.Based on the device testing and investigation performed on the device at sag, no device malfunction could be found.As it can be proved that the device does not malfunction, the device worked as intended during the intervention and the disconnects either by the accessories (defi bads) or due to patient's condition.Therefore this case is considered as not reportable.
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Search Alerts/Recalls
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