• 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 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

  • 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 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) Back to Search Results
Model Number 20
Device Problems Failure to Charge (1085); Device Inoperable (1663); Device Sensing Problem (2917)
Patient Problem No Patient Involvement (2645)
Event Date 09/23/2014
Event Type  malfunction  
Event Description
The customer contacted physio-control to report that a service indicator was displayed on their device and an event code was logged.There was no patient use associated with the reported event.Upon evaluation of the device, physio-control observed that the device was not able to read an ecg signal through the paddles lead.When this occurred an event code was logged in the device memory.Without this functionality the device would not have the ability to function in aed mode.It was also observed that the device would not charge for defibrillation therapy and would intermittently lock up upon boot up of the device.
 
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported failure.Physio-control replaced the system controller and user interface pcb assemblies.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Physio-control further evaluated the removed system controller pcb assembly and determined that the cause of the reported issue was a shorted integrated circuit (ic) chip, designator u17.Physio-control observed that ic chip u17 would load down the power supply, causing an event code to log in the memory and prevent paddles lead ecg from operating.It was also observed that ic chip u17 also caused intermittent device lockup during the boot up sequence and prohibited the device from charging for defibrillation therapy.The removed user interface pcb assembly was an ancillary part and there was no failure of this assembly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
Manufacturer (Section D)
PHYSIO-CONTROL, INC
11811 willows road ne
po box 97006
redmond WA 98073 970
Manufacturer (Section G)
PHYSIO-CONTROL, INC
11811 willows road ne
po box 97006
redmond WA 98073 970
Manufacturer Contact
jason march
4258674000
MDR Report Key4238047
MDR Text Key4998303
Report Number3015876-2014-01328
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063119
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/09/2014
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 Number20
Device Catalogue Number3202488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2014
Is the Reporter a Health Professional? Yes
Device Age8 YR
Event Location Hospital
Initial Date Manufacturer Received 10/09/2014
Initial Date FDA Received11/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-