• 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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to physio control.A third-party service agent evaluated the customer's device and verified the reported issue.After replacing the therapy pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
 
Event Description
The customer contacted physio-control to report that their device had illuminated its service led and logged an event code into its memory that's indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.  the defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.  there was no report of patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and found the reported issue was due to transistor, designator q27.Pin 5 to 9 were shorted in diode, designator cr30, which was caused by burning from transistor, designator q26.The purpose of transistor, designator q27 is to aid in the turn off of cr30 which should lead to the device shut off after energy is delivered.The issue with transistor, designator q27 resulted in an initial shock being biphasic, but further shocks being monophasic and less energy when tested on a mock-up device, in either a defibrillation shock or during a user test.Device delivered shock, then turned off.The root cause of the reported issue was identified as transistor, designator q27.
 
Event Description
The customer contacted physio-control to report that their device had illuminated its service led and logged an event code into its memory that's indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no report of 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
MDR Report Key9521261
MDR Text Key189991574
Report Number0003015876-2019-02073
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 02/25/2020
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 NumberUNK_SMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Initial Date Manufacturer Received 11/29/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received01/30/2020
Supplement Dates FDA Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-