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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 Incorrect Interpretation of Signal (1543)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2023
Event Type  malfunction  
Event Description
A customer contacted stryker to report that their device gave a 'no shock advised' analysis for a rhythm that was believed to be shockable.As a result, wrong defibrillation therapy would be delivered.The patient associated with the reported event did not survive.
 
Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Stryker 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.
 
Manufacturer Narrative
The electronic patient record was downloaded.Stryker performed a clinical review and it was determined that the device did not contribute to the patient outcome.A stryker technician evaluated the customer's device and was unable to duplicate or verify the reported issue.The cause of the reported issue could not be determined.
 
Event Description
A customer contacted stryker to report that their device gave a 'no shock advised' analysis for a rhythm that was believed to be shockable.As a result, wrong defibrillation therapy would be delivered.The patient associated with the reported event did not survive.
 
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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
brian blakeslee
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key18541353
MDR Text Key333194001
Report Number0003015876-2024-00143
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-000496
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/22/2023
Initial Date FDA Received01/19/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
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