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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CR2
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Manufacturer Narrative
The customer received a replacement lid.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
 
Event Description
The customer contacted physio-control to report that their device¿s lid magnet was missing from the lid.As a result, the device may not automatically power on when the lid is opened.This may lead to defibrillation therapy being delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.Stryker replaced the device's lid to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.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¿s lid magnet was missing from the lid.As a result, the device may not automatically power on when the lid is opened.This may lead to defibrillation therapy being delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
 
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Brand Name
LIFEPAK 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 Key12533506
MDR Text Key273363899
Report Number0003015876-2021-01838
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-000735
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2018
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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