Model Number 15 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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The customer contacted physio-control to report that their device powered off by itself during a patient event.The crew was able to manually power the device back on.This issue is patient related; however there was no adverse patient outcome reported.The customer advised that there were no adverse effects to the patient as a result of the reported issue.Later back at the station while performing test shocks, the customer observed the device displayed an energy fault message.
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Event Description
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The customer contacted physio-control to report that their device powered off by itself during a patient event.The crew was able to manually power the device back on.This issue is patient related; however there was no adverse patient outcome reported.The customer advised that there were no adverse effects to the patient as a result of the reported issue.Later back at the station while performing test shocks, the customer observed the device displayed an energy fault message.
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Manufacturer Narrative
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Physio-control evaluated the customer¿s device but was unable to duplicate the reported issue.Physio downloaded the electronic records from the customer¿s device and was able to confirm that their device experienced an inappropriate loss of power.Physio replaced the power pcb assembly, the battery wire harness assembly and the battery pins, then completed other unrelated repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio-control determined that the cause of the reported issue was fretting corrosion on the battery wire harness contacts of connector j11 and the mating power pcb assembly contacts of connector p11 and worn battery pins.The fretting corrosion on j11/p11 and worn battery pins, can all increase the resistance of the input power path.This increase in resistance can result in a sudden loss of device power under conditions of high current usage from functions such as printing a code-summary® record.The excessive voltage drop at the contacts triggers the power fail detector circuit on the power board, which causes the device to power cycle.
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Search Alerts/Recalls
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