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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 Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted physio-control to report that their device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed if needed or may lead to use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue through an analysis of the device log.Physio determined that the likely cause of the reported issue was the lid switch, designator sw5.The customer received a replacement device and physio archived the returned device.
 
Event Description
The customer contacted physio-control to report that their device would not power on when the device lid was activated.In this state defibrillation therapy may be delayed 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 Key12558853
MDR Text Key274252819
Report Number0003015876-2021-01875
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-001453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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