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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 Problems Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2021
Event Type  malfunction  
Event Description
The customer contacted physio-control to report that their device was missing the magnetic pin the lid.In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.
 
Manufacturer Narrative
The customer has been provided with a replacement lid.  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 magnetic pin the lid.In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.
 
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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
MDR Report Key11547945
MDR Text Key242289294
Report Number0003015876-2021-00621
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873824092
UDI-Public00883873824092
Combination Product (y/n)N
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-001265
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number3015876-01/14/2021-001-C
Patient Sequence Number1
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