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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 Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customers device and was unable to duplicate the reported issue.After proper device operation was observed through functional and performance testing, the device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that their device "defib pads not reading." in this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to this event.
 
Manufacturer Narrative
Physio-control determined that the cause of the issue was user error.
 
Event Description
The customer contacted physio-control to report that their device "defib pads not reading." in this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient involvement associated to this event.
 
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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 Key12478798
MDR Text Key271653414
Report Number0003015876-2021-01777
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873871706
UDI-Public00883873871706
Combination Product (y/n)N
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/11/2021
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 Health Professional
Device Model Number15
Device Catalogue Number99577-001956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Initial Date Manufacturer Received 08/19/2021
Initial Date FDA Received09/15/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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