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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CRPLUS
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information was not provided were intentionally left blank.Physio-control 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
The customer contacted physio-control to report that their device repeatedly gave a "connect pads" message during a patient event.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
 
Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.The device was retained by stryker and the customer received a replacement device.The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report that their device repeatedly gave a "connect pads" message during a patient event.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There were no reports of any adverse effects to the patient as a result of the reported issue.
 
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Brand Name
LIFEPAK CR® 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 Key12712989
MDR Text Key278831665
Report Number0003015876-2021-02072
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873820551
UDI-Public00883873820551
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCRPLUS
Device Catalogue Number99403-000156
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2016
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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