Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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(R) 20 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(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the user interface to stack flex assembly cable.Thereafter, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the removed user interface to stack flex assembly cable.It was determined that the flex cable was torn at the c1 location, which caused the reported issue.
 
Event Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
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
megan marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7579295
MDR Text Key110457496
Report Number0003015876-2018-00884
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-