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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Unexpected Shutdown (4019)
Patient Problem Arrhythmia (1721)
Event Date 08/26/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient and device.No response has been received from the customer.Patient and device fields in which information is not provided were intentionally left blank.Physio-control evaluated the customers device and was unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report that their device repeated this action of shutting off, prompting the crew to turn it back on a total of 5 times.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue by viewing the device's electronic files.The customer noted that after the call they found one battery was not fully seated in the device.The cause of the reported issue is determined to be user error from not having the battery fully seated.The device passed all functional and performance testing and was returned to the customer.
 
Event Description
The customer contacted physio-control to report that their device repeated this action of shutting off, prompting the crew to turn it back on a total of 5 times.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
 
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Brand Name
LIFEPAK 15 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key12508548
MDR Text Key272541906
Report Number0003015876-2021-01812
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873871683
UDI-Public00883873871683
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Date Manufacturer Received10/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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