PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,V2; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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Model Number 15 |
Device Problem
Failure to Sense (1559)
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Patient Problem
Asystole (4442)
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Event Date 10/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.Physio-control will not request any patient identifying information to be in accordance with regulation (b)(4) of the european parliament and of the council.Physio-control continues to investigate the reported failure 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 their device would not display an ecg trace through the therapy accessory.In this state the device may not be able to deliver defibrillation therapy if needed.A second set of electrode-pads was used and patient care was continued.The patient associated with the reported event did not survive, however the health care provider involved stated that they do not believe the device use contributed to the patient outcome.
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Manufacturer Narrative
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The customer informed physio-control that they are completing an internal investigation, and believe the cause of the reported issue may have been use error.The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.
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Event Description
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The customer contacted physio control to report that their device their device would not display an ecg trace through the therapy accessory.In this state the device may not be able to deliver defibrillation therapy if needed.A second set of electrode-pads was used and patient care was continued.The patient associated with the reported event did not survive, however the health care provider involved stated that they do not believe the device use contributed to the patient outcome.
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