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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CR2
Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2019
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The customer was sent a replacement device.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.
 
Event Description
The customer contacted physio-control to report that their device was missing the magnet from the lid of the device.In this state the device will not turn on automatically when the lid is activated, which can cause a delay in defibrillation therapy if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.
 
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Brand Name
LIFEPAK(R) CR2 DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key11266817
MDR Text Key230997730
Report Number0003015876-2021-00239
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873824115
UDI-Public00883873824115
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-001263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2020
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received02/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number3015876-01/14/2021-001-C
Patient Sequence Number1
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