JOLIFE AB - 3005445717 LUCAS 2, 2.1 SW, IN SHIPPING BOX,EN,EN INTL; COMPRESSOR, CARDIAC, EXTERNAL
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Model Number LUCAS |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2021 |
Event Type
Death
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Manufacturer Narrative
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This mdr is being submitted to correct the incorrect manufacturing site and related fields that were previously submitted under 3005445717-2021-00010.Due to character limitations initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank. though physio-control requested some patient information, physio will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.A physio-control service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After completing some unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Clinical review of the reported event was performed.It can not be excluded that the failing of the device contributed to the patient death even if the survival rate in this transported patient population is low.
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Event Description
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A customer contacted physio-control to report that their device failed during intervention on a patient.The device alarmed and stopped.The patient did not survive reported event.The healthcare provider confirmed that the device use contributed to the patient outcome.
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Search Alerts/Recalls
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