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® 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
Medical Device Problem Code Failure to Analyze Signal (1539)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
 
Event or Problem Description
The customer contacted physio-control to report that they have multiple devices that are not correctly identifying shockable rhythms as shockable.As a result, defibrillation therapy may not be available to a patient, if it was needed.There was no report of patient use associated with the reported event.Physio-control contacted the customer to request additional information on the devices and the events.No response has been received from the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFEPAK® 20E DEFIBRILLATOR/MONITOR
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8691496
Report Number0003015876-2019-01027
Device Sequence Number19316648
Product Code MKJ
UDI-Device Identifier00883873892107
UDI-Public00883873892107
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K130454
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/12/2019
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
Operator of Device Health Professional
Device Model Number20E
Device Catalogue Number11150-000019
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-