Model Number 865351 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Insufficient Information (4580)
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Event Date 09/12/2023 |
Event Type
Death
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Manufacturer Narrative
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Section e reporter phone #: (b)(6).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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Event Description
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It was reported recently a patient expired.No additional details have been provided at this time and it is unclear if this event has already been reported.
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Manufacturer Narrative
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Per the response received via the customer the philips remote service engineer (rse) stated that the data for the second death mentioned is not made available despite asking for it.However, the rse confirmed that the customer wanted the data from the unit for review, and there was no implication of a fault.Based on the information provided in the case, the device was confirmed to be operating per specifications and no failure was identified.
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Event Description
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The customer reported that the mx40 patient wearable monitor was indicating the death on a patient wearing the device.
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Manufacturer Narrative
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D4 unique device identifier (udi) was corrected to no information as the customer was unable to provide the serial number.
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Search Alerts/Recalls
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