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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 Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Event Description
A customer contacted stryker to report that the magnet was damaged in the lid of their device.This will result in an inability of the device to detect the lid being opened or closed.In this state, a delay in defibrillation may occur, as the users has to push the power button underneath the lid to turn the device on.There were no reports of patient use associated with the reported event.
 
Manufacturer Narrative
The customer will be provided with a replacement lid.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.Device not returned.
 
Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.It was observed that the magnet was damaged no longer the specified length, it was found to be 10 mm but should be 15.875 mm.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.
 
Event Description
A customer contacted stryker to report that the magnet was damaged in the lid of their device.This will result in an inability of the device to detect the lid being opened or closed.In this state, a delay in defibrillation may occur, as the users has to push the power button underneath the lid to turn the device on.There were no reports 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 Key15321128
MDR Text Key303412331
Report Number0003015876-2022-01972
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFI
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 02/01/2023
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 Number99512-001271
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/08/2022
Initial Date FDA Received08/30/2022
Supplement Dates Manufacturer Received01/05/2023
Supplement Dates FDA Received02/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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