PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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Model Number CRPLUS |
Device Problems
Invalid Sensing (2293); Device Sensing Problem (2917)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control determined that the cause of the reported issue was that a capacitor, designator c178, on the analog pcb assembly had process residue.The process residue made the voltages for legs 5, 6, and 7 of an integrated circuit (ic), designator u15, to not be the correct voltage values which kept the ecg waveform at a flat line.The customer was provided with a replacement device.
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Event Description
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The customer contacted physio-control to report that their device had a service wrench present on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order to charge and shock, if it were necessary.
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Manufacturer Narrative
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Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank section d4 of the initial medwatch report should indicate: device identifier (di) number ¿ (b)(4).
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Event Description
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The customer contacted physio-control to report that their device had a service wrench present on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order to charge and shock, if it were necessary.
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