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) 15 MONITOR/DEFIBRILLATOR; 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) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problems Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of the customer¿s device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted physio-control to report that their device was unable to deliver defibrillation energy during a patient event.The customer advised that the on the forth shock attempt the monitor advised "shock abnormal" but the shock was still administered and the service indicator became illuminated.While attempting to give another shock, the device was unable to deliver the shock, however the patient went into asystole thereafter.This issue is patient related; however there was no adverse patient outcome reported.No further details were provided by the customer.Physio-control made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event, but has been unsuccessful.
 
Manufacturer Narrative
Physio-control further evaluated the customer's device and replaced the therapy pcb assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio further evaluated the removed therapy pcb assembly.It was observed that transistor, designator q8 was electrically shorted and caused no energy output to be delivered, an ¿abnormal energy delivered¿ message to be displayed, event codes to be logged and the main capacitor to dump into the inductive resistor shortly after the shock button was pressed.
 
Event Description
The customer contacted physio-control to report that their device was unable to deliver defibrillation energy during a patient event.The customer advised that the on the forth shock attempt the monitor advised "shock abnormal" but the shock was still administered and the service indicator became illuminated.While attempting to give another shock, the device was unable to deliver the shock, however the patient went into asystole thereafter.This issue is patient related; however there was no adverse patient outcome reported.No further details were provided by the customer.Physio-control made multiple attempts to contact the customer in order to obtain additional information about both the patient and the event, but has been unsuccessful.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key9189177
MDR Text Key190684943
Report Number0003015876-2019-01686
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873871683
UDI-Public00883873871683
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/11/2019
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 Number99577-001958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2019
Initial Date Manufacturer Received 09/30/2019
Initial Date FDA Received10/14/2019
Supplement Dates Manufacturer Received11/08/2019
Supplement Dates FDA Received11/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-