PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
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Model Number CR2 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control evaluated the device and verified the issue of missing lid magnet.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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It was reported; lifepak cr2 device customer states, " 'device not ready' and 'replace battery' messages." upon further inspection; physio control found, "device returned without lid magnet".In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.There is no report of patient involvement associated to this event.
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Event Description
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It was reported; lifepak cr2 device customer states, " 'device not ready' and 'replace battery' messages." upon further inspection; physio control found, "device returned without lid magnet".In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.There is no report of patient involvement associated to this event.
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Manufacturer Narrative
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An engineering investigation has determined that due to the design of the lcpr2 lid switch, absence of the lid magnet allows current to flow from the battery, even when the device is in standby mode.This will reduce the life of the battery.Therefore, the reported issue, the loss of lid/lid magnet, is associated with two hazardous situations: opening the lid does not turn on the device, and, higher than intended current draw while the device is in standby mode results in a prematurely depleted the battery.Replacement of the device lid so that the magnet is present in the device allows the lid switch to function as designed; turning on/off the device when the lid is opened and preventing current draw when the device lid is closed.The lpcr2 operating instructions has been updated to include additional troubleshooting tips to direct the customer to act when device behavior indicates the lid magnet may be missing.A new warning informs the customer of the risk associated with a missing magnet.The device was archived by stryker and the customer has been provided with a replacement device.
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