Model Number 866199 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2022 |
Event Type
malfunction
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Event Description
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It was reported to philips that the device displays an x even though the device passed testing.There was no patient involvement.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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Manufacturer Narrative
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Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
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Manufacturer Narrative
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This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart dfm100 indicating that red x remained on.There was no patient involvement.The fse evaluated the device on site.It was determined that this was a malfunction of the battery signal internal cable which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.This complaint investigation has been impacted by logistical limitations associated with the service parts supply chain (sps) returns process.This limitation is beyond the immediate control of the complaint handling group.No further investigation of the component is possible until the limitations are resolved.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the battery signal internal cable.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The battery signal internal cable was replaced to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
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Search Alerts/Recalls
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