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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CRPLUS
Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Power Up (1476); Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2022
Event Type  malfunction  
Manufacturer Narrative
Stryker evaluated the customer's device and observed that the device would not power on.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.
 
Event Description
A customer contacted stryker to report that their device had displayed its service wrench icon.Upon initial evaluation, stryker observed that device would not power on.The device was physically damaged but the extent of the damage is unknown.There was no patient use associated with the reported event.
 
Manufacturer Narrative
The device can no longer be repaired.The customer approved to scrap the device.Stryker product analysis center further evaluated the device and verified that the device would not power on.The cause of the reported issue was due to depleted hlc battery.The device was powered on with ac power and during evaluation, it was observed that the device would not provide defibrillation shock.It was observed that the therapy connector was unseated and it appeared that the device has been exposed to an unknown source of force or tamper.The cause of the reported issue was due to disconnected therapy connector.
 
Event Description
A customer contacted stryker to report that their device had displayed its service wrench icon.Upon initial evaluation, stryker observed that device would not power on.The device was physically damaged but the extent of the damage is unknown.There was no patient use associated with the reported event.
 
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Brand Name
LIFEPAK CR(R) PLUS 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 Key14548806
MDR Text Key293148279
Report Number0003015876-2022-00821
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K033275
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 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCRPLUS
Device Catalogue Number99403-000209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2022
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2011
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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