• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Physio-control evaluated the customers device and was unable to duplicate the reported issue. After completing other unrelated repairs,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 is delivering abnormal energy during daily test. In this state the device may deliver an inappropriate defibrillation therapy if needed. There was no patient use reported with the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFEPAK® 20E DEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED 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 Key9648308
MDR Text Key190777745
Report Number0003015876-2020-00143
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20E
Device Catalogue Number99507-000133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-