Model Number 00-3020 |
Device Problems
Circuit Failure (1089); Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191); No Pacing (3268)
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Patient Problems
Dyspnea (1816); Unspecified Heart Problem (4454); Insufficient Information (4580)
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Event Date 06/29/2021 |
Event Type
Death
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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 (b)(6) female (dob: (b)(6)) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.
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Event Description
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The incident described as follows by the customer - patient was 74 yo female (dob: (b)(6) 1946) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.
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Manufacturer Narrative
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The customer was to return the tempus ls manual failure device.The tracking number (b)(4) given by customer is invalid and customer said that she can¿t provide any further information.Philips engineer called ups they have no record of a pick-up from that location from 7-28-21 to 8-20-21.Further checked with philips warehouse in mechanicsburg, pa where the device (sn: (b)(6)) was to be sent and device not received until 11 nov 2021.
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Event Description
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The incident described as follows by the customer - patient was 74 yo female (dob: (b)(6) 1946) with complaint of sob.Ekg: wide complex junctional rhythm.During transport paramedic attempted to pace patient and received the error message - check electrodes.Ems not able to access the pacing feature on tempus ls.It was reported the patient outcome was patient died.After arriving back at station personnel compared the action of the defib to another known good tempus ls and the two units did not work the same.Pacing feature was no able to be accessed on reported device.Electrode pads were placed on ems personnel and they continued to receive "check electrodes" error message.The device has been received and sent to manufacturer for investigation.It was found that the internal cable connecting the ecg connector to the print was not in the correct position.Based on the traces, it must be assumed that this cable was mounted correctly.The cable has come loose due to twisting of the ecg connector.Such an error should be noticed during the daily function test.According to log files the daily function tests were not done as required by the to ifu.
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Manufacturer Narrative
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Updated contact information , problem code , evaluation result code , component coded and conclusion code.
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Search Alerts/Recalls
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